New Drugs and Technologies

Overview of New Technologies for Lower

Extremity Revascularization
Jason H. Rogers, MD; John R. Laird, MD

Abstract—Lower extremity peripheral arterial occlusive disease poses a unique challenge to traditional angioplasty-based
endovascular therapies. The diffuse nature of lower extremity atherosclerotic disease, the presence of chronic total
occlusions, poor distal runoff, and the presence of critical limb ischemia all have contributed to the disappointing results
of balloon angioplasty for complex infrainguinal arterial disease. These challenges have spawned the development of
a host of new technologies in an attempt to improve the safety and effectiveness of percutaneous revascularization for
lower extremity peripheral arterial occlusive disease. This review summarizes the recent advances in available
technologies, including novel angioplasty balloons; nitinol stents, stent grafts, and drug-eluting stents; excisional, laser,
and rotational atherectomy devices; devices for crossing total occlusions; true-lumen reentry devices; thrombectomy
catheters; and embolic protection devices. (Circulation. 2007;116:2072-2085.)
Key Words: catheter 䡲 lower extremity 䡲 peripheral vascular diseases 䡲 technology
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T he limitations of percutaneous transluminal angioplasty

(PTA) for the treatment of lower extremity peripheral
arterial occlusive disease (PAOD) are well established. Al-
available data supporting the use and potential role of these
emerging technologies.

though PTA can be an effective modality for focal lesions in
the iliac arteries,1,2 the results of balloon angioplasty for
complex infrainguinal arterial disease have been disappoint-
ing.3–5 Although incompletely studied, numerous factors have
been identified that negatively affect the long-term results of
PTA. These include the length of the diseased segment, the
presence of total occlusion, diabetes mellitus, poor distal
runoff, and critical limb ischemia as the clinical presenta-
tion.6,7 Chronic total occlusion may be present in up to 20%
to 40% of patients undergoing treatment for symptomatic
PAOD, and procedural success rates have historically been
lower in the setting of chronic total occlusion.7,8 In addition,
there is greater potential for complications such as distal
embolization and perforation when balloon angioplasty is
used for long occlusions and more complex disease. These
limitations of PTA have spawned the development of a host
of new technologies in an attempt to improve on the safety
and efficacy of percutaneous revascularization for lower
extremity PAOD (Figure 1). Many of the devices presented
here have been shown to improve procedural and clinical
outcomes. However, the lack of uniform performance criteria
and reporting standards for new devices has resulted in
heterogeneous study end points, making comparative efficacy
difficult. Future trials should attempt to adhere to perfor-
mance criteria that have been developed for superficial
femoral artery (SFA) intervention and will likely be devel-
oped for other vascular beds.9 This review summarizes the
Novel Angioplasty Balloons
Despite improvements in balloon catheter materials, lower
balloon crossing profiles, and the availability of longer
balloons for peripheral arterial use, plain old balloon
angioplasty (POBA) continues to be limited by problems
of dissection, acute elastic recoil, and restenosis caused by
intimal hyperplasia and negative remodeling. These fail-
ings have led to the development of alternative balloon
modalities, including cutting or scoring balloons and
cryoplasty.
Cryoplasty
Cryoplasty is a technique that combines balloon angioplasty
and cold therapy. Cooling of the balloon is achieved by the
use of liquid nitrous oxide as the balloon inflation media
rather than the usual mixture of contrast and saline. This
cooling is hypothesized to have several beneficial effects,
including plaque modification, reduction of elastic recoil, and
induction of apoptosis in the smooth muscle cells in the
vessel wall within the treated segment.10 Although no in vivo
human data currently exist, it is thought that cryoplasty-
induced smooth muscle cell apoptosis may reduce prolifera-
tion rates essential to the restenotic process. The PolarCath
(Boston Scientific, Natick, Mass) is a commercially available
cryoplasty system approved for peripheral arterial use. The
system consists of a disposable computerized inflation con-
trol unit, nitrous oxide cylinder, and balloon catheter (Figure
2). As the liquid nitrous oxide is shuttled into the balloon, it

From the Vascular Center and Division of Cardiovascular Medicine, University of California, Davis Medical Center, Sacramento.
Correspondence to John R. Laird, MD, Vascular Center and Division of Cardiovascular Medicine, University of California, Davis Medical
Center, 4860 Y St, Ste 3400, Sacramento, CA 95817. E-mail john.laird@ucdmc.ucdavis.edu
© 2007 American Heart Association, Inc.
Circulation is available at http://circ.ahajournals.org DOI: 10.1161/CIRCULATIONAHA.107.715433

2072
 Rogers and Laird
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Figure 1. Overview of new technologies for lower extremity revascularization.
undergoes a phase shift, resulting in inflation of the balloon
and cooling to the desired temperature of ⫺10°C. Balloon
inflation occurs in 2-atm increments up to the nominal
inflation pressure of 8 atm. The treatment cycle lasts 20
seconds before deflation and passive warming of the balloon.
Repeat inflations can be performed as needed by replacing
the nitrous oxide canister. The PolarCath is available in
diameters from 2.5 to 8 mm and lengths from 2 to 10 cm. The
smaller-diameter balloons have a 0.014-in guidewire lumen
Lower Extremity Revascularization Technologies 2073
and are designed for infrapopliteal use. The larger balloons
have a 0.035-in guidewire lumen.
The PolarCath system was evaluated in a prospective,
multicenter registry of cryoplasty for the treatment of lesions
in the SFA and popliteal artery. Ultimately, 102 patients with
stenoses or occlusions up to 10 cm in length were enrolled at
15 centers in the United States. Procedural success was 94%,
with a need for bailout stenting resulting from a suboptimal
angiographic result in only 9% of cases. Significant dissec-
 2074 Circulation October 30, 2007
Figure 2. The PolarCath system. A computerized inflation unit
with a disposable nitrous oxide cylinder controls inflation and
cooling of the balloon catheter to ⫺10°C.
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tion (grade C or greater) occurred in only 7% of cases. This
finding compares favorably with historical data regarding
dissection rates after POBA. Primary clinical patency (free-
dom from target vessel revascularization) was 82.8% at 9
months. Duplex-derived primary patency at 9 months was
70.1%. Primary assisted and secondary patency rates were
94% and 98%, respectively.11 Extended follow-up data on 70
patients from the multicenter registry at ⬎3 years (1253 days)
from the procedure demonstrated that the clinical patency rate
was well maintained at 75%.12
An additional prospective, multicenter registry of cryo-
plasty for infrapopliteal lesions in patients with critical limb
ischemia has been completed. A total of 111 limbs in 106
patients (mean lesion length, 4 cm) were treated at 16 centers
in the United States with 1-year follow-up available. Most
patients presented with tissue loss (ulceration, 66.4%; gan-
grene, 36.8%). Acute procedural success was 97%, with a
low incidence of major or minor dissection (1% and 6%,
respectively). The limb salvage rate at 1 year was 85%.13
These results can be placed in the perspective of 1-year
outcomes from the multicenter Bypass Versus Angioplasty in
Severe Ischemia of the Leg (BASIL) trial. In this study,
patients with severe limb ischemia had 1-year amputation-
free survival rates of 68% in the surgical arm and 71% in the
angioplasty arm.14
In summary, cryoplasty appears safe and effective for
femoropopliteal and infrapopliteal occlusive disease. No
randomized data are available; however, the acute angio-
graphic outcomes are favorable, with a low incidence of
dissection and an infrequent need for bailout stenting. The
9-month and longer patency rates in these shorter lesions
compare favorably with historical PTA outcomes, but com-
parative studies are necessary to determine whether cryo-
plasty offers any real advantage over PTA or stenting.
Cutting and Scoring Balloons
There is considerable experience with cutting and scoring
balloons in the coronary circulation for a variety of different
applications. Recently, the cutting balloon (Boston Scientific)
was made available in larger diameters and was approved for
peripheral vascular use. The peripheral cutting balloon comes
in 2 lengths (1 and 2 cm) and in 5-, 6-, 7-, and 8-mm
diameters. Each device has 4 longitudinal microsurgical
blades bonded to the balloon. The proposed mechanism of
action is a focusing of the dilation force at the tips of the
atherotomes to provide scoring of the lesion and more gentle
dilatation of the vessel with less vessel wall disruption.
Potential benefits of the cutting balloon include reduced
elastic recoil and more effective dilatation of fibrotic, anas-
tomotic, or calcified lesions with less risk of major dissection.
The lack of availability of balloons longer than 2 cm makes
this device impractical for the treatment of diffuse disease or
long occlusions in the femoropopliteal and infrapopliteal
vessels. The cutting balloon has shown promise, however, for
the treatment of anastomotic or intragraft lesions within
saphenous vein bypass grafts. In a small study,15 19 infrain-
guinal vein graft stenoses were treated with a procedural
success rate of 100%. A good hemodynamic result was
documented on follow-up duplex imaging, and at a mean
follow-up of 11.4 months, only 1 patient developed a recur-
rent stenosis. A larger, more recent study16 compared POBA
with the Cutting balloon as the primary treatment for failing
infrainguinal bypass grafts in 36 patients. Although initial
technical success was higher with the cutting balloon (74%
versus 82%), the primary patency at 12 months was 36% (9
of 25) for POBA and 50% (5 of 10) for cutting balloon
angioplasty (P⫽0.47).
Another potential application for the cutting balloon is to
treat focal, calcified, or ostial lesions in the infrapopliteal
vessels. Ansel and colleagues17 reported on their experience
treating 93 popliteal and tibial lesions in 73 patients with the
cutting balloon. Procedural success was 100%, with a need
for bailout stenting as a result of dissection or suboptimal
angiographic result in 20%. For those patients presenting with
critical limb ischemia (Rutherford category ⱖ4), the limb
salvage rate at 1 year was 89.5%.
The AngioSculpt balloon (AngioScore, Inc, Fremont,
Calif) is another scoring device approved for peripheral
vascular use. It consists of a semicompliant balloon with an
external nitinol shape-memory helical scoring edge. A pro-
posed advantage of this nitinol edge is improved device
flexibility and deliverability. Further studies are required to
better understand the role of the AngioSculpt balloon and the
potential advantages of this device over the cutting balloon or
standard balloon angioplasty.
Nitinol Stents
Nitinol is a unique alloy composed of nearly equal parts of
nickel and titanium.18 Nitinol has 2 unique characteristics:
superelasticity (ie, it returns to its original shape when an
external force is removed) and thermal shape memory (it
returns to a preformed shape on warming, allowing self-
expansion). The superelasticity and thermal shape memory of
the alloy make nitinol stents resistant to compression at body
temperature and help them to resist external deformation.
They are therefore more ideally suited for deployment in
areas of flexion and torsion such as the superficial femoral
and popliteal arteries.
 Rogers and Laird
Although a multitude of nitinol stent designs are available
from different manufacturers, only 1 nitinol stent (IntraCoil,
ev3, Plymouth, Minn) has been approved by the US Food and
Drug Administration for femoral use. The other nitinol stents
are approved for biliary or iliac artery use and are implanted
“off-label” in the femoropopliteal arteries. The IntraCoil
stent, which is constructed from a single strand of nitinol
wire, is wound into the shape of a simple coil. This design has
distinct advantages and disadvantages with regard to use in
the SFA and popliteal arteries. For example, although the coil
design affords the stent extreme flexibility and resistance to
fracture, the low ratio of metal surface to open area provides
less complete plaque coverage. Furthermore, the coiled de-
sign makes stent deployment less controlled than with other
nitinol stent designs, and foreshortening of the stent on
release makes positioning less precise than desired. US Food
and Drug Administration approval of the IntraCoil stent was
based on results of a randomized trial comparing its use with
balloon angioplasty for femoropopliteal lesions. Although the
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complete results of the IntraCoil randomized trial have not
been published, outcomes of the roll-in phase of the trial, in
which all patients were treated with the IntraCoil stent, were
published by Ansel and colleagues.19 They treated 93 patients
with obstructive femoropopliteal artery disease up to 15 cm in
length with the IntraCoil stent. In the patients who had a
successful procedural outcome, the 9-month follow-up
showed that 77.9% remained free of major adverse clinical
events and that 81.8% had not required target lesion revas-
cularization. Over the same follow-up period, the mean
ankle-brachial index increased from 0.66 to 0.83, whereas the
mean maximum walking time increased from 4.47 to 5.91
minutes.19
Despite the fact that the only US Food and Drug Admin-
istration–approved nitinol stent has a coil configuration, the
majority of nitinol stents being implanted today have a mesh
design, which affords improved scaffolding and plaque cov-
erage. Mewissen20 evaluated the SMART stent (Cordis,
Miami Lakes, Fla) prospectively in 137 lower limbs in 122
patients with chronic limb ischemia. The anatomic subtypes
included TransAtlantic Inter-Society Consensus A lesions in
12 limbs and B or C lesions in 125 limbs. The mean lesion
length was 12.2 cm (range, 4 to 28 cm), and 57% of the
lesions were ⬎10 cm in length. Technical success was
achieved in 98% of cases, and there were no acute (30-day)
stent occlusions. At 1 and 2 years, the hemodynamic primary
patency rates determined by duplex ultrasound were 76% and
60%, respectively.20
In a randomized controlled trial, Schillinger and col-
leagues21 assigned 104 patients with severe claudication or
chronic limb ischemia caused by stenosis or occlusion of the
SFA to undergo primary stent implantation (51 patients) with
the Absolute self-expanding stent (Abbott Vascular, Red-
wood City, Calif) or angioplasty (53 patients). In that study,
the mean length of the treated segment was 132⫾71 mm in
the stent group and 127⫾55 mm in the angioplasty group.
Secondary stenting was performed in 17 of 53 patients (32%)
in the angioplasty group, in most cases because of a subop-
timal result after angioplasty. The angiographic restenosis
rate at 6 months was 24% in the stent group and 43% in the
Lower Extremity Revascularization Technologies 2075
angioplasty group (P⫽0.05); at 1 year, the restenosis rates by
duplex ultrasonography were 37% and 63%, respectively
(P⫽0.01). Patients in the stent group were able to walk
significantly farther on a treadmill than were those in the
angioplasty group at 6 months (average distance, 363 versus
270 m; P⫽0.04) and 12 months (average distance, 387 versus
267 m; P⫽0.04). The ankle-brachial index also was signifi-
cantly better at 12 months in the stent group compared with
the angioplasty group (P⫽0.03).21
Table 1 summarizes the main findings of available studies
examining the use of nitinol stents in femoropopliteal arteries.
The intermediate-term data for nitinol stents are promising,
with 1- and 2-year primary patency rates superior to those for
PTA and for first-generation stents. However, clear limita-
tions remain, including the risk of restenosis after the use of
nitinol stents and the potential for nitinol stent fracture in
particular. Restenosis appears to occur more frequently when
stents are used for long-segment disease and in diabetics. This
restenosis appears to occur later than restenosis after coronary
artery stenting. Late restenosis (after 1 year) has been noted to
occur in most studies of SFA stenting.
In the long-segment study conducted by Sabeti and col-
leagues,22 stent fractures were observed in 15% of cases. The
incidence of stent fracture was significantly associated with
the length of the stented segment, with longer stents more
likely to fracture. There was a trend toward increased risk of
restenosis in fractured stents, although statistical significance
was not achieved.22 The surprising finding of a high incidence
of nitinol stent fracture has been confirmed by Scheinert and
colleagues.23 These researchers investigated the incidence of
femoral nitinol stent fractures by radiographic screening in 93
patients (121 limbs) at a mean follow-up of 10.7 months after
stent implantation. The mean length of the stented segments
in their patients was 15.7 cm. Stent fractures were found in 45
of 121 treated legs (37.2%) and in 64 of 261 stents (24.5%).
The stent fractures were classified as minor (single strut
fracture) in 31 cases (48.4%), moderate (fracture of ⬎1 strut)
in 17 cases (26.6%), and severe (complete separation of stent
segments) in 16 cases (25.0%). Fractures occurred in 13.2%
of cases when the stented length was ⬍8 cm, 42.4% with a
stented length of 8 to 16 cm, and 52.0% when the stented
length was ⬎16 cm. Furthermore, in 21 cases (32.8%), there
was ⬎50% diameter reduction at the site of stent fracture. In
22 cases (34.4%) with stent fracture, there was total stent
occlusion. According to Kaplan-Meier estimates, the primary
patency rate at 12 months was significantly lower for patients
with stent fractures (41.1% versus 84.3%; P⬍0.0001). This
study demonstrates that stent fracture is not merely a benign,
incidental finding but may in fact be associated with a higher
risk of restenosis and occlusion.23
More flexible and fracture-resistant nitinol stents have
been developed in response to these concerns regarding stent
fracture and late restenosis. Further data regarding the per-
formance of one such stent will be forthcoming from the
RESILIENT trial (Randomized Study Comparing the Ed-
wards Self-Expanding Life Stent vs Angioplasty Alone in
Lesions Involving the Superficial Femoral Artery or Proximal
Popliteal Artery), a randomized comparison of the Lifestent
NT (Edwards Lifesciences, Irvine, Calif) with balloon angio-
 2076 Circulation October 30, 2007

Table 1. Major Trials Reporting Patency for Nitinol Stents in Femoropopliteal Arteries
Author/Study Artery/Lesion Stenoses or Mean Lesion Primary Patency,
(Year) Patients, n Type of Stent Type Occlusion, n (%) Length, cm %
Lugmayr et al61 44 (54 limbs) Symphony stent (Boston SFA and Stenoses, 32 (59); Stenoses, 3.2; At 1 y, 87; at
(2002) Scientific, Natick, Mass) popliteal occlusions, 22 (41) occlusions, 4.0 3 y, 76
artery Stenoses: at
1 y, 94; at 3 y,
78 Occlusions; at
1 and 3 y, 77
Jahnke et al62 37 (40 lesions) Intracoil (Intratherapeutics, SFA, 33; Stenoses, 23 (58); 3.6 At 1 y, 86.2
(2002) St Paul, Minn) popliteal, 4; occlusions, 17 (42)
TASC A and B
Vogel et al63 41 SMART or Precise stents SFA, 35; 6.69 At 1 y, 84; at
(2003) (Cordis, Johnson & popliteal, 6; 2 y, 84
Johnson Co, Miami TASC B and C
Lakes, Fla)
Sabeti et al22 52 SMART stent (Cordis, SFA and Stenosis, 24 (46); 6.0 At 1 y, 75; at
(2004) Johnson & Johnson Co); popliteal occlusions, 28 (54) 2 y, 69
Dynalink stent (Guidant, artery
Santa Clara, Calif);
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Expander stent (Bolton

Medical, Nancy, France)
Mewissen et al20 122 (137 limbs) SMART stent (Cordis, SFA and 12.2 At 1 y, 76; at
(2004) Johnson & Johnson Co) popliteal 2 y, 60
artery; TASC
A, 12; TASC
B and C,
125
Duda et al26–28/ 93: Sirolimus and bare SMART SFA; all Stenoses, 36 (39); 8.2 At 2 y, 88.1
SIROCCO (2006) 47 Sirolimus-eluting stent (Cordis, Johnson & TASC C occlusions, (sirolimus group,
nitinol stents, Johnson Co) 57 (61): 31 in 87.1; bare stent
46 bare nitinol sirolimus group group, 88.9)
stents and 26 in bare
stent group
Schillinger et al21 51 Dynalink or Absolute stent SFA Stenoses, 32 (63); 10.1 At 1 y, 63 on
(2006) (Guidant, Santa Clara, occlusions, 19 (37) duplex
Calif) ultrasonography
TASC indicates TransAtlantic Inter-Society Consensus.

plasty for SFA and proximal popliteal artery lesions up to 15
cm in length.
Nitinol Stent Grafts and Covered Stents
Stent grafts have been developed as therapy for femoropop-
liteal occlusive disease in an effort to duplicate the surgical
gold standard of femoropopliteal bypass with either vein or
synthetic graft material. One such device, the Viabahn endo-
prosthesis (W.L. Gore & Associates, Inc, Flagstaff, Calif), is
a self-expanding helical nitinol stent mounted to the outside
surface of a tube of expanded polytetrafluoroethylene. The
device is deployed into a target lesion after predilation, with
the expanded polytetrafluoroethylene membrane postulated
to act as a barrier to neointimal formation. The Viabahn
endoprosthesis is currently approved by the US Food and
Drug Administration for use in patients with symptomatic
superficial femoral arterial lesions with reference vessel
diameters of 4.8 to 7.5 mm. The device comes in 6-, 7-, and
8-mm diameters and is available in 2.5-, 5-, 10-, and 15-cm
lengths.
Kedora et al24 performed a randomized, prospective study
comparing the treatment of SFA occlusive disease percuta-
neously with the Viabahn stent (n⫽50) and surgical femoral-
to-above-knee popliteal artery bypass with synthetic graft
material (n⫽50). Primary patency at 12 months was not
statistically different between the stent graft group and the
surgical group (73.5% versus 74.2%, respectively). There
were 14 reinterventions in the stent graft group and 12
reinterventions in the surgical group, resulting in similar
secondary patency rates of 83.9% and 83.7%.24 The ongoing
Viabahn Versus Bare Nitinol Stent (VIBRANT) trial is a
randomized, prospective, multicenter trial intended to exam-
ine the performance of the Viabahn endoprosthesis compared
with bare metal stents. Enrollment is currently underway,
with planned 3-year follow-up and duplex ultrasound surveil-
lance at 1-, 6-, 12-, 24-, and 36-month intervals.
Stent grafts also may be useful for aneurysmal disease,
given their unique ability to exclude the vessel wall from the
lumen. In a small recent study, 16 patients with 23 popliteal
artery aneurysms were treated with the Viabahn endoprosthe-
sis. Complete aneurysm exclusion was achieved in all cases,
and during the mean follow-up of 7 months, only 1 patient
became symptomatic as a result of stent-graft thrombosis that
occurred at 6 months and was successfully treated with repeat
 Rogers and Laird
percutaneous intervention. With primary and secondary pa-
tency rates at 12 months of 93% and 100%, respectively, this
approach appears promising for an initial endovascular ap-
proach in these patients.25
For patients with aneurysmal iliac disease, balloon-
expandable covered stents may be used. The iCAST covered
stent (Atrium Medical Corp, Hudson, NH) is a balloon-
expandable stent with 316L stainless steel struts that are
completely covered with microporous polytetrafluoroethyl-
ene, which may result in improved deliverability and more
uniform radial expansion. The stent is available in 5- to
12-mm diameters, which allows treatment of aneurysms
and/or iatrogenic perforations/dissections in a variety of
vessel sizes. The iCAST stent also will be evaluated in an
upcoming multicenter trial for the treatment of iliac artery
occlusive disease. The JOSTENT GraftMaster (Abbott Vas-
cular) is another balloon-expandable covered stent available
in 3- to 5-mm diameters that can be used to treat perforations
in smaller vessels.
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Drug-Eluting Stents
There are currently no approved peripheral drug-eluting
stents for use within the United States. This reflects the facts
that drug elution has yet to be widely applied to the peripheral
arterial circulation and that clinical trials to date involving the
superficial femoral arteries have not mirrored the initial
successes seen with coronary drug-eluting stents.
Nonetheless, there is a need for improved patency rates
after stenting because reported restenosis rates are as high
as 75% for the superficial femoral, popliteal, and tibial
arteries. Specific challenges to stent-based revasculariza-
tion of the SFA include diffuse disease, which is often
occlusive; involvement of the adductor canal; low-flow/
high-resistance conditions; and coexistent disease of distal
runoff vessels. Indeed, the physiological stresses on stents
in the infrainguinal location appear to be a major factor in
limiting long-term device performance. Neointimal hyper-
plasia is only one of multiple failure modes, which include
stent fracture, incomplete stent expansion, malapposition
resulting from mechanical forces and calcification, and
impaired endothelialization with thrombosis.
The Sirolimus Coated Cordis SMART Nitinol Self-Expan-
dable Stent for the Treatment of SFA Disease (SIROCCO)
trials used a thin uniform coating (5 to 10 ␮m) of sirolimus in
a dose concentration equivalent to coronary stents (90 ␮g/cm2
or 1 mg total per 6⫻80 cm SMART stent). The SIROCCO I
trial randomized 36 patients with SFA disease (defined as
ⱖ70% stenoses [ⱖ7 to ⱕ20 cm] or total occlusion [ⱖ4 to
ⱕ20 cm] with a maximum of 3 stents) to either sirolimus-
eluting or bare metal stents. Although this study failed to
reach the primary end point of improved in-stent mean
percent diameter stenosis by quantitative angiography
(22.6% in the sirolimus group versus 30.9% in the control
group; P⫽NS), there appeared to be an advantage in the
subgroup of 5 patients who received the slower-eluting
sirolimus stent. Other possible confounding factors in-
cluded excessive calcification in the sirolimus arm and a
total of 6 stent fractures, 3 in the sirolimus arm and 3 in the
control arm.26
Lower Extremity Revascularization Technologies 2077
The SIROCCO II trial was designed to expand on the
findings of SIROCCO I by randomizing 57 patients to
slower-eluting sirolimus stents or control stents. Patients with
shorter ⱖ70% stenoses (ⱖ7 to ⱕ14.5 cm) or total occlusions
(ⱖ4 to ⱕ14.5 cm) were enrolled and treated with a maximum
of 2 stents. This study again failed to meet its primary end
point of in-stent mean lumen diameter at 6 months as
determined by quantitative angiography (4.94⫾0.69 and
4.76⫾0.54 mm for sirolimus-eluting and bare metal groups,
respectively; P⫽NS).27
A pooled analysis and longer-term follow-up of the
slower-eluting formulation from SIROCCO I and II re-
sulted in an early statistically significant difference in the
primary end point (mean stent diameter); however, this
advantage was lost by 18 months as determined by duplex
sonography.28
Another drug-eluting stent currently under investigation in
the above-the-knee femoropopliteal artery is the Zilver PTX
Stent Platform (Cook Medical, Bloomington, Ind), a self-
expanding nitinol stent. Drug elution is via polymer-free
paclitaxel applied to the abluminal surface only. The pacli-
taxel is applied in a 3-␮g/mm2 dose density, with a 220- to
880-␮g total dose per stent. The first phase of a nonrandom-
ized trial has been completed outside the United States in 60
patients with SFA lesions ⱕ7 cm, allowing 1 stent per lesion.
Twenty patients (28 lesions) were treated with the Zilver PTX
stents, with a primary patency rate of 90% (mean follow-up,
9 months; range, 6 to 12 months). By intravascular ultra-
sound, no aneurysm or strut malapposition was associated
with the Zilver PTX stents, and no stent fractures were seen.
The second expanded study phase will add 420 randomized
patients (lesions ⱕ14 cm, up to 2 stents per lesion) with
planned 12-month follow-up to further evaluate safety and
effectiveness. The planned primary end point is event-free
survival defined as freedom from the major adverse events of
death, target lesion revascularization, target limb ischemia
requiring surgical intervention, surgical repair of the target
vessel, and worsening Rutherford classification. The second-
ary end point will be patency rate at the 6- and 12-month
follow-up as assessed by duplex ultrasound.29
Bare balloon-expandable and nitinol self-expanding stents
have been used below the knee to treat severe claudication or
critical limb ischemia with high immediate procedural suc-
cess rates. Limb salvage rates at 1 to 12 months have been
reported to be 80% to 96%.30 –32 Because infrapopliteal
vessels are of small caliber with long lesion lengths, drug
elution has been proposed to be of particular benefit. There
are limited data reporting the off-label use of sirolimus-
eluting coronary stents in below-the-knee applications. Bo-
siers et al30 reported that when sirolimus-eluting balloon-
expandable coronary stents were used in the infrapopliteal
arteries, a 6-month follow-up demonstrated survival and limb
salvage rates of 94.4% and 94%, respectively, with a mean
late lumen loss of only 0.38 mm. Siablis et al33 found
significantly less in-stent and in-segment binary restenosis
and a decreased rate of repeat endovascular procedures at 1
year in sirolimus-eluting versus bare metal stents. Further
studies are needed to assess the safety and efficacy of this
approach. Finally, a recent randomized trial demonstrated
 2078 Circulation October 30, 2007
that a paclitaxel-coated balloon catheter (Paccocath) was
effective in reducing the 6-month mean late lumen loss and
binary restenosis when used in the SFA.34 Although drug
elution, whether stent based or balloon based in the periphery,
is an exciting prospect, many issues remain to be resolved,
including the ideal pharmacological agent and release kinet-
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ics, the elimination of stent fractures, and the cost-to-benefit
ratio.
Debulking Devices: Excimer Laser and
Excisional Atherectomy
A variety of atherectomy and laser angioplasty systems have
been used to treat PAOD in the past with mixed results. In
recent years, there has been a resurgence of interest in
debulking devices with the development of a new excisional
atherectomy system (SilverHawk, Fox Hollow Technologies,
Redwood City, Calif) and improvement in excimer laser
atherectomy catheters (ClirPath, Spectranetics Corp, Colo-
rado Springs, Colo) and laser technique.
Excimer Laser Atherectomy
Continuous-wave, hot-tipped lasers were evaluated and aban-
doned for peripheral arterial use in the late 1980s because of
high complication rates caused by thermal damage to sur-
rounding tissue.35 In contrast, excimer laser–assisted angio-
plasty of the leg arteries has been practiced commercially in
Europe since 1994. The 308-nm excimer laser uses flexible
fiberoptic catheters to deliver intense bursts of ultraviolet
energy in short pulse durations. The advantage of ultraviolet
light lies in its short penetration depth of 50 ␮m and in its
ability to break molecular bonds directly by a photochemical
rather than thermal process. The excimer laser catheter
removes a tissue layer of 10 ␮m with each pulse of energy.
Tissue is ablated only on contact, without a consequent rise in
temperature to surrounding tissue. An additional benefit of
ultraviolet light is its ability to ablate thrombus and to inhibit
platelet aggregation.36
Potential advantages of laser atherectomy include the
ability to treat long occlusions and complex disease effec-
tively, thereby providing a better angiographic result with less
distal embolization and less need for stenting. The excimer
laser also may be used to facilitate crossing of chronic total
occlusions using the “step-by-step” technique in which the
guidewire is advanced just proximal to the lesion and the
excimer laser catheter is brought into contact with the occlu-
sion. The laser catheter is gently advanced ahead and acti-
Figure 3. The “step by step” technique. The
excimer laser catheter is used to penetrate
the fibrous cap of the chronic total occlusion.
The laser catheter and guidewire are advanced
in tandem through the occlusion until access to
the true lumen beyond the occlusion is
achieved.
vated for 5 to 10 seconds in an attempt to penetrate the fibrous
cap. The guidewire is then used to probe antegrade to find a
channel through the lesion. If a channel cannot be found, the
laser is reactivated, and the above technique is repeated
(Figure 3). Scheinert and colleagues37 analyzed the results of
411 consecutive excimer laser–assisted recanalization proce-
dures for long SFA occlusions (mean occlusion length, 19.4
cm) in 318 patients. Despite the treatment of long occlusions,
the technical success rate was high (90.5%). Bailout stenting
was needed in only 7.3% of cases. Other complications were
infrequent and included acute reocclusion (1%), perforation
(2.2%), and distal embolization (3.9%). The primary patency
rate at 1 year was disappointing; however, with careful
surveillance and early reintervention, a secondary patency
rate of 75.1% at 1 year was achieved after treatment of these
long SFA occlusions.37
Excimer laser–assisted intervention also has been evalu-
ated for the treatment of complex occlusive disease in
patients presenting with critical limb ischemia. In the Laser
Angioplasty for Critical Limb Ischemia (LACI) trial, 145
patients (155 critically ischemic limbs) were treated with
excimer laser–assisted intervention at 15 sites in the United
States and Germany. All patients were poor candidates for
surgical revascularization because of diffuse distal disease,
with poor targets for bypass, the absence of venous conduit,
or significant medical or cardiac comorbidities placing the
patient at high risk for complications from surgery. A total of
423 lesions were treated in the SFA (41%), popliteal (15%),
and infrapopliteal (41%) arteries. The majority of patients
(70%) had a combination of stenoses and occlusions, and the
mean treatment length was ⬎16 cm. Despite these unfavor-
able lesion and patient characteristics, an excellent limb
salvage rate of 93% was achieved at 6 months.38
There have been numerous improvements in laser catheter
technology over the years. A limiting factor has always been
the inability to create a channel much larger than the diameter
of the catheter. This limitation has been addressed with the
latest design iteration, the TURBO-Booster catheter (Spec-
tranetics; Figure 4). The TURBO-Booster uses a custom
guide catheter that allows the laser to directionally ablate
tissue to obtain a larger lumen. The device is currently
undergoing evaluation for the treatment of disease in the
SFA and popliteal arteries in the multicenter ClirPath
Excimer Laser to Enlarge Lumen Openings (CELLO)
clinical trial.
 Rogers and Laird
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Excisional Atherectomy
The SilverHawk Plaque Excision System (Fox Hollow Tech-
nologies) is a forward-cutting atherectomy device. When the
catheter is activated and manually advanced through a lesion,
a high-speed cutting blade excises a ribbon of plaque that is
collected into the catheter nose cone. Multiple catheter passes
are made through the lesion, during which the blade is
redirected sequentially toward all quadrants of the vessel
lumen. Significant debulking of the lesion can be achieved
without the barotrauma associated with the previous direc-
tional atherectomy catheter that uses a balloon opposite the
cutting blade to maximize plaque removal.
The SilverHawk catheter now comes in 7 different sizes to
allow treatment of femoral, popliteal, tibial, and even pedal
vessels. Two of the catheters have extra-large nosecones for
greater plaque capacity, whereas the MS catheter has a
slightly lower-profile blade that was designed for greater
efficacy in calcified lesions. Some of the catheters feature a
design modification that allows easier flushing of the
nosecone.
There are no prospective, randomized trials comparing
excisional atherectomy with the SilverHawk catheter to
balloon angioplasty or stenting. Several single-center experi-
ences with the SilverHawk have been published. Zeller and
colleagues39 have published their experience with femoro-
popliteal excisional atherectomy. They treated 131 lesions in
100 limbs in 84 patients presenting with Rutherford category
2 to 5 ischemia. Forty-five lesions were de novo (group 1;
34%), 43 lesions were native vessel restenoses (group 2;
33%), and 43 lesions were in-stent restenoses (group 3; 33%).
The technical success rate was 86% for atherectomy alone
and 100% after adjunctive therapies. Primary patency, de-
fined as freedom from ⬎50% restenosis by duplex ultrasound
at 18 months, was 73%, 42%, and 49% in the 3 groups,
respectively. The secondary patency rates at 18 months were
89%, 67%, and 79%, respectively. The authors concluded
that long-term technical and clinical results after atherectomy
of femoropopliteal lesions are in favor of de novo lesions
compared with restenotic lesions.39
Lower Extremity Revascularization Technologies 2079
Figure 4. The TURBO-Booster catheter.
A 2.0-mm excimer laser catheter is
advanced through the TURBO-Booster
catheter to allow directional laser atherec-
tomy. The orientation of the laser corre-
sponds to the appearance of the orienta-
tion band.
Kandzari and colleagues40 also evaluated SilverHawk
atherectomy for patients presenting with critical limb ische-
mia (Rutherford category 5 to 6). A total of 76 limbs were
treated in 69 patients at 7 centers in the United States.
Approximately 40% of the lesions treated were in the
infrapopliteal vessels. Procedural success was achieved in
99% of cases. Complications were infrequent, and target
lesion revascularization occurred in only 4% of cases. Limb
salvage (avoidance of major amputation) was achieved in
87% of patients at 6 months.40 The role of excisional
atherectomy for the treatment of critical limb ischemia is to
be evaluated further in a prospective, randomized clinical trial
comparing SilverHawk atherectomy with the gold standard of
surgical bypass (PROOF trial: Plaque Removal versus Open
Bypass Surgery for Critical Limb Ischemia).
Future developments will be directed at designing a cath-
eter with greater capability to excise calcified plaque and one
that incorporates imaging (optical coherence tomography or
intravascular ultrasound) to better direct plaque excision. In
addition, the opportunity to study excised atherosclerotic
plaque more intensively has led to a partnership between Fox
Hollow Technologies and Merck Research Laboratories with
a goal of developing novel target therapies to treat
atherosclerosis.
Rotational Atherectomy
This resurgence in interest in atherectomy devices for periph-
eral vascular use has led to the development of 2 new
rotational atherectomy systems that are currently in clinical
trials. The Pathway Medical PV (Pathway Medical Technol-
ogies, Redmond, Wash) system has expandable, rotating
scraping blades (“flutes”) with ports between the flutes that
allow flushing and aspiration of plaque material or thrombus.
The Orbital Atherectomy System (Cardiovascular Systems,
St Paul, Minn) is a high-speed rotational atherectomy system
that incorporates an eccentric, diamond-coated abrasive
crown. When rotated at high speeds, the abrasive crown
moves in an orbital path within the artery, potentially creating
a lumen larger than the diameter of the crown while gener-
 2080 Circulation October 30, 2007
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ating only small particles that will pass through the capillary
circulation (Figure 5).
Percutaneous Thrombectomy
The clinical consequences of arterial thrombus formation or
thromboembolism in the lower extremity are significant. If
peripheral arterial or graft occlusion occurs acutely, thrombus
is almost invariably present. This may occur as a result of in
situ thrombosis of a ruptured plaque or cardioembolism. If
collaterals are minimal or absent, acute limb ischemia may
result, and therapy must be delivered urgently. In the pres-
ence of chronic stenoses with varying degrees of collateral
formation, thrombotic occlusion may result in severe claudi-
cation or in a more subacute presentation of limb ischemia.
Clinically significant distal thromboembolism during periph-
eral percutaneous intervention also may occur, necessitating
distal aspiration embolectomy. Percutaneous rheolytic and
aspiration thrombectomy catheters have been developed to
address these clinical scenarios.
Rheolytic Thrombectomy
The Angiojet rheolytic thrombectomy system (Possis Medi-
cal, Inc, Minneapolis, Minn) consists of a pump set and drive
unit that delivers pressurized saline to the tip of the rheolytic
catheter to produce a series of retrograde-directed high-
velocity saline jets that entrain thrombus through hemody-
namic forces (Bernoulli’s principle/Venturi effect). Throm-
bus is then fragmented by the saline jets and aspirated
mechanically through the effluent lumen.41 Six Angiojet
catheters currently are available that can accommodate a wide
variety of vessel diameters and clinical applications. Potential
advantages of the Angiojet system include the ability to
rapidly remove a large amount of fresh thrombus burden in an
ischemic limb without the need for chemical thrombolysis
with the attendant risks of bleeding. Limitations include the
potential for distal embolization (the use of an embolic
protection during rheolytic thrombectomy should be consid-
ered), the inability to remove chronic or insoluble thrombus,
Figure 5. New rotational atherectomy sys-
tems. A, The Pathway PV Atherectomy
System control pod and catheter. B, Mag-
nified view of catheter tip. The scraping
flutes can be expanded with counterrota-
tion for greater luminal enlargement. C,
Orbital atherectomy device and controller.
D, Magnified view of the eccentric abrasive
crown.
and difficulty in treating the microvasculature. Fortunately,
hemolysis with localized adenosine release resulting in bra-
dycardia is not a risk in the periphery as it is with intracoro-
nary use.
The Angiojet catheter has been shown to be effective in the
treatment of acutely occluded infra-aortic native arteries and
bypass grafts, with the majority of acute thrombotic material
(⬎75%) being removed. For more organized residual or
mural thrombus and underlying atherosclerotic lesions, ad-
junctive angioplasty with stent placement may be required.42
The rheolytic catheter has been used successfully in conjunc-
tion with catheter-directed thrombolysis in one series of 86
patients with acute and subacute limb-threatening ischemia.
After primary rheolytic thrombectomy was performed, sec-
ondary catheter-directed thrombolysis was performed in 50
patients, yielding a high acute success rate (⬎50% luminal
clearance in 84% of treated patients) with a reported 6-month
patency rate of 79%.43 The rheolytic catheter also can be used
in a combined “power-pulse spray” technique. In this method,
a chemical thrombolytic is first infused into the thrombus in
a stepwise manner through the rheolytic catheter by occlud-
ing the outflow port. After the thrombus has been “laced”
with thrombolytic, the same catheter is used to aspirate the
thrombus. This technique has been reported to be safe and
allows rapid sequential chemical and rheolytic thrombec-
tomy, with success rates ⬎90%.44
Aspiration Thrombectomy
Thrombus aspiration also can be achieved with an aspiration
catheter. Syringe suction is applied manually to a catheter,
with thrombus entrained in the catheter by this extraction
force. Although the efficiency and volume of thrombus
extracted with these catheters are not equivalent to those of
rheolytic catheters, the advantages of these catheters include
ease of use and deliverability to small-caliber distal vascula-
ture. The most common application in the lower extremity
would therefore be the management of distal embolization
during peripheral intervention.
 Rogers and Laird
Several aspiration catheters are currently available for use
in the peripheral vasculature. The Pronto V3 extraction
catheter (Vascular Solutions, Minneapolis, Minn) has a dual-
lumen, monorail design that is compatible with a 6F guiding
catheter and a 0.014-in wire. Thrombus is extracted by
bringing the catheter to the desired site over a wire, and
aspiration is performed using two 30-mL locking vacuum
syringes. The unique feature of this catheter is the rounded
distal tip (“olive”) that sits in front of the aspiration orifice.
This design may improve thrombus aspiration and protect the
vessel wall while advancing during aspiration. The Pronto
catheter has been shown to be effective in the intracoronary
circulation, but there are no published trials examining its
efficacy in the lower extremity vasculature.45
Another effective aspiration catheter is the Export XT
catheter (Medtronic Vascular, Inc, Minneapolis, Minn). This
catheter features a forward-facing aspiration orifice, which
engages thrombus at a different angle than the Pronto
catheter. Manual aspiration is achieved by two 30-mL locking
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syringes. The Export XT catheters are monorail, 0.014-in
wire compatible, and available in 6F guide-compatible
(0.041-in aspiration lumen) and 7F guide-compatible
(0.050-in lumen) sizes. Other aspiration catheters include the
Rio Catheter (Boston Scientific) and the Diver CE (ev3 Inc),
which has multiple side holes designed to improve flow and
minimize clogging.
Embolic Protection in Lower
Extremity Revascularization
Embolic protection devices (EPDs), first developed to pro-
vide cerebral protection during carotid artery stenting, have
led to marked reductions in the combined end points of stroke
or death.46,47 It was therefore natural that these devices should
be applied to native coronary and aortocoronary saphenous
vein graft interventions in an effort to reduce clinically
significant atheroembolism and thromboembolism. Many of
these devices have been used in the lower extremities,
although this translation offers unique challenges. Vessel
diameters in the lower extremities often span a wide range not
met by all EPDs, and the burden of thrombus and/or athero-
embolic material often far exceeds that seen in the carotid or
coronary circulation. Delivery of EPDs in the lower extremity
vasculature may be more difficult in view of typically longer
diseased segments, and retrieving the filters with captured
debris also may be challenging. An advantage of EPD use in
the lower extremities is that transient vessel occlusion gen-
erally will not be a major issue as it can be in the cerebral or
coronary circulation.
Despite multiple clinical trials in carotid artery stenting and
saphenous vein graft intervention, there are currently few data
to support the routine use of an EPD in patients undergoing
routine lower extremity peripheral vascular intervention.
Nonetheless, the use of EPDs is likely warranted in thrombus-
laden lesions or in patients with vessels with poor distal
runoff on the basis of reported rates of distal embolization
during thrombolytic therapy in limb-threatening ische-
mia.48 –51 In addition, routine EPD use may be warranted
during femoropopliteal excisional atherectomy on the basis of
Lower Extremity Revascularization Technologies 2081
data from one series that demonstrated embolic debris re-
trieved in 10 consecutive cases.52
Types of EPDs
There are 3 main types of EPDs available: distal filtration,
distal balloon occlusion, and proximal occlusion devices.
Proximal occlusion generally is not used during lower ex-
tremity revascularization, given the long length of distal
runoff and multiple collaterals. The interventionalist’s choice
of EPD depends on a variety of factors, including feasibility,
device familiarity, ease of use, cost, and perceived efficacy.
The number, size, and volume of particulate debris liberated
by stenting saphenous vein grafts have been studied in
comparisons of distal balloon occlusion with a distal vascular
filter having an average distal pore size of 100 ␮m. The
distribution of particle sizes and embolic load captured was
equivalent.53 These data and others are important in estab-
lishing the principle that despite a nominal pore size of ⬇100
␮m, the functional orifice size of a filter is smaller, likely
because of the deposition of aggregate debris, platelets, or
fibrin on the filter surface.54 A summary of currently avail-
able EPDs that can be adapted for use in the lower extremities
is given in Table 2.
Devices for Chronic Total Occlusions
Critical limb ischemia and claudication typically arise in the
presence of chronic total occlusions. In such cases, collateral
flow often is insufficient to alleviate symptoms. Critical limb
ischemia develops when those collaterals are jeopardized by
more proximal occlusive disease. The ability to successfully
traverse and recanalize these chronic total occlusions is
therefore imperative. Attempts at recanalization of these often
heavily calcified lesions fail in ⬇20% of cases using tradi-
tional guidewire and balloon technology. The reason for
failure stems primarily from the inability to cross a lesion or
the inability to reenter the distal true lumen from a subintimal
location. Because of this clinical need, several devices have
recently become available to assist in this important lesion
subset.
Devices for Crossing
Controlled Blunt Microdissection
Controlled blunt microdissection refers to the ability to perform
catheter-based microdissection using a pair of miniature hinged
jaws that can be actuated from the catheter handle. Controlled
blunt microdissection has been reported to be safe and feasible,
with a 91% success rate in treating pelvic and lower limb chronic
total occlusions in 1 series of 36 patients with 44 symptomatic
chronic total occlusions that had failed conventional percutane-
ous revascularization.55 In this report by Mossop et al, a
prototype catheter with hinged jaws was used to create a channel
through the lesion using controlled blunt microdissection and,
when paired with a true-lumen reentry device, resulted in a very
high procedural success rate. This technology, which is now
marketed as the FrontRunner XP chronic total occlusion catheter
(Cordis), is intended to facilitate the intraluminal placement of
conventional guidewires beyond stenotic lesions (including
chronic total occlusions) in the peripheral vasculature before
further percutaneous intervention. The current-generation device
 2082 Circulation October 30, 2007

Table 2. EPDs Applicable to the Lower Extremity Vasculature

Distal Occlusion Distal Filter Proximal Occlusion
GuardWire (Medtronic, Minneapolis, Minn) FilterWire EZ (Boston Scientific) Facilitated Aspiration/Suction Thrombectomy
0.014-in wire 0.014-in wire (Funnel Catheter, Genesis Medical
Interventional, Redwood City, Calif)
2.8F crossing profile 3.2F crossing profile
Wide-mouthed funnel catheter
10-mm landing zone 110-␮m pore size
Focused vacuum
6F guide compatible 6F guide compatible
Quick on/off
18-mm landing zone
GuardDog (Possis Medical Inc, Minneapolis, Minn) AngioGuard XP (Cordis)
0.035-in wire 0.014-in wire
3- to 6-mm vessel diameter compatible 3.2F crossing profile
CO2 inflation device 100-␮m pore size
7F guide compatible
18-mm landing zone
SpiderFX (ev3, Plymouth, Minn)
0.014-in wire
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3.2F crossing profile

3.0- to 7.0-mm sizes
167- to 209-␮m pore size
Heparin-coated filter
6F guide compatible
TriActiv FX (Kensey Nash, Exton, Pa) Emboshield (Abbott Vascular, Proxis (St Jude Medical, Minneapolis, Minn)
Redwood City, Calif)
Accunet (Abbott Vascular) Gore Neuro Protection (Gore & Associates,
Flagstaff, Az)
Rubicon (Boston Scientific) Mo.Ma Occlusion System (Invatec,
Roncadelle, Italy)
Interceptor Plus (Medtronic)

consists of a handle assembly and integrated catheter rotator, a
proximal braided and distal shapeable shaft, and a distal micro-
dissection tip composed of bilateral hinged pieces. The crossing
profile is 0.039 in with the jaws closed, reaches a maximum
diameter of 2.3 mm with the jaws open, and is available in 90-
and 140-cm lengths. The device does not have a guidewire
lumen, and once a lesion is crossed, a dedicated MicroGuide
catheter is advanced over the FrontRunner catheter to its tip, and
the catheter is then withdrawn. A guidewire can then be placed
through the MicroGuide over which further therapies such as
balloons and stents may be delivered.
CROSSER Catheter
The CROSSER chronic total occlusion recanalization system
(FlowCardia Inc, Sunnyvale, Calif) is an innovative device
that uses high-frequency mechanical vibrations (20 000 cy-
cles per second to a depth of 20 ␮m) propagated through a
nitinol core wire to a stainless steel tip. The system consists
of a generator, transducer, foot switch, and disposable cath-
eter. The generator applies AC current to the piezoelectric
crystals in the transducer, which then converts, amplifies, and
transmits this energy to the catheter tip. The vibrational
mechanical impact and cavitational effects result in penetra-
tion of the occluded artery. The catheter is 1.1 mm in
diameter, monorail, and hydrophilic; can be mounted on a
standard 0.014-in guidewire; and is compatible with a 6F
guiding catheter. Although there are no maximum recommen-
dations for vessel size, a minimum diameter of 2.5 mm is
recommended. Although the infusion lumen of the
CROSSER is too small to aspirate blood, it is possible to
inject diluted contrast to confirm true-lumen position. An
irrigation line is required for continuous sterile saline flush
through the device during activation, which cools the system
and helps to facilitate cavitation at the catheter tip.
The CROSSER system has previously been studied in
chronic total occlusions in the coronary circulation with high
technical success rates (63% to 76%).56,57 The ongoing
Peripheral Approach to Recanalization in Occluded Totals
(PATRIOT) trial is a US multicenter trial currently enrolling
patients to assess the safety and efficacy of using the
CROSSER catheter in chronic femoropopliteal occlusions
resistant to conventional guidewire technique.
True-Lumen Reentry
Multiple technologies are now available to allow passage
of a guidewire beyond an occlusion or stenosis, but this is
often in a subintimal fashion. Reentering the true lumen
with conventional guidewires is often a lengthy and
unsuccessful venture. Two devices are currently available
that facilitate true-lumen reentry. In addition to ensuring a
high success rate in reentering the true lumen, these
 Rogers and Laird
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devices may reduce the chance of vessel perforation and
procedure times.
OutBack LTD Reentry Catheter
The OutBack LTD reentry catheter (Cordis) is 120 cm in
length with a single 0.014-in wire lumen and a 5.9F profile
(6F sheath compatible). The catheter consists of a deploy-
ment handle mounted to a rotating hemostasis valve, which
is attached to the proximal catheter shaft. At the distal end
of the catheter is a 22-gauge reentry cannula (needle). The
device is passed over a 0.014-in wire into the subintimal
space adjacent to the desired reentry location. Orienting
the catheter under fluoroscopy by means of distal “L” and
“T” markers at the end of the catheter shaft aligns the
cannula with the true lumen. The wire is then partially
withdrawn, and the cannula is advanced into the true
lumen by moving the deployment slide forward. The wire
can then be advanced into the true lumen, and conventional
therapies can be delivered (Figure 6).
The OutBack catheter was first evaluated in an earlier
generation in a series of 36 patients with peripheral (primarily
iliac and femoral) chronic total occlusions initially ap-
proached with percutaneous controlled blunt microdissection.
Of all successful cases, 35% (14 of 40) required true-lumen
Lower Extremity Revascularization Technologies 2083
Figure 6. True-lumen reentry with the Out-
Back LTD catheter. A, Chronic total occlu-
sion of the distal right SFA. B, The heavily
calcified occlusion does not allow
advancement of a hydrophilic guidewire
into the true lumen beyond the occlusion.
C, A catheter is advanced subintimally
beyond the occlusion to allow exchange
for a 0.014-in guidewire. D, The OutBack
reentry catheter is advanced over this
guidewire and is rotated so that the “L” at
the tip of the catheter is directed toward
the true lumen. E, The needle is pushed
forward, allowing the guidewire to be
advanced into the true lumen beyond the
occlusion. F, Final result after stent
implantation.
reentry, which was successfully achieved with this first-
generation device.55 In another series by Joye et al58 of 100
consecutive endovascular occlusions in which the distal true
lumen could not be reentered, there was a reported 95%
clinical success rate in reentering the true lumen with avail-
able reentry catheters and successfully completing the
intervention.
Pioneer Catheter
Another device designed to assist true-lumen reentry is the
Pioneer catheter (Medtronic). This catheter incorporates a
distal 25-gauge nitinol reentry needle with an integrated
64-element phased-array intravascular ultrasound trans-
ducer to allow directed ultrasound-guided reentry into the
true lumen (Figure 7). This catheter is 120 cm long,
accommodates two 0.014-in guidewires (1 to track the
device and 1 for the reentry needle), and is compatible with
a 7F sheath. The device is brought into the subintimal tract
over a wire, and under intravascular ultrasound imaging,
color flow is identified in the true lumen. The catheter is
rotated to position the true lumen at the “12 o’clock”
position, after which the needle is advanced and the true
lumen is wired. The Pioneer catheter can then be removed,
and the intervention may proceed. Prior studies have
 2084 Circulation October 30, 2007
Figure 7. The Pioneer reentry catheter. An ultrasound trans-
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ducer at the tip of the catheter helps to guide reentry into the
true lumen from the subintimal space during advancement of
the curved, hollow needle.
shown the Pioneer catheter to be safe and effective in
true-lumen reentry, with low recanalization times for
endovascular chronic total occlusions (ⱕ10 minutes).59,60
In our hands, this device is particularly useful for reenter-
ing the true lumen during attempts at retrograde recanali-
zation of iliac artery chronic total occlusions.
Conclusions
It is evident that the last decade has seen an unprecedented
rate of new device development for the treatment of PAOD.
These advancements have made it possible to treat a vast
array of lesion subsets with focused technologies and high
acute procedure success rates. However, significant limita-
tions remain in the currently available technologies. The
diffuse nature of vascular occlusive disease continues to
complicate endovascular approaches to revascularization.
Long-term target vessel patency after mechanical therapies
remains suboptimal, and careful postprocedure surveillance
with adjunctive imaging modalities frequently is required.
Although we have made tremendous advances in the
endovascular treatment of lower extremity arterial occlusive
disease, vital improvements in the next decade will depend on
sustained clinical and basic investigations that carefully meld
both existing and emerging technologies.
Disclosures
Dr Rogers is a consultant for Boston Scientific and Medtronic. Dr
Laird is a consultant for Cordis, Boston Scientific, Medtronic,
Edwards Life Sciences, ev3, and Spectranetics.
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 Overview of New Technologies for Lower Extremity Revascularization
Jason H. Rogers and John R. Laird

Circulation. 2007;116:2072-2085
doi: 10.1161/CIRCULATIONAHA.107.715433
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