| Eligibility |
Cohort 1: General Inclusion Criteria:
1. Has symptomatic leg ischemia, requiring treatment of the SFA and/or popliteal artery.
2. Has a Rutherford Clinical Category of 2 - 4. Note: Rutherford Clinical Category 2
subjects should be entered into the study if conservative treatment has been
unsuccessful.
3. Is =18 years old.
4. Has life expectancy >1 year.
5. Is able and willing to provide written informed consent prior to study specific
procedures.
6. Is willing and capable of complying with the required follow-up visits, testing
schedule and medication regimen.
Cohort 1: Angiographic Inclusion Criteria:
1. Has evidence at the target lesion(s) of clinically and hemodynamically significant de
novo stenosis or restenosis, or occlusion, in the SFA (1 cm distal to the ostium of
the profunda) and/or popliteal artery (proximal to the popliteal trifurcation),
confirmed by angiography.
2. Has target limb with at least one patent (<50% stenosis) tibio-peroneal run-off vessel
to the foot confirmed by baseline angiography or magnetic resonance angiography (MRA)
or computed tomography angiography (CTA). Note: Treatment of outflow disease is NOT
permitted.
3. Has 1 or 2 target lesion(s) with a cumulative lesion(s) length of no more than 20 cm.
Note: A maximum of two (2) lesions can be treated if the cumulative total lesion
length (i.e. the combined length of both lesions) is less than or equal to 20cm.
4. Has target lesion(s) located >2 cm from any stent if the target vessel was previously
stented.
5. Has a reference vessel diameter of 4 - 6 mm by visual estimate.
6. Has a successful exchangeable guidewire crossing of the lesion(s).
Cohort 1: General Exclusion Criteria:
1. A female who is pregnant, of childbearing potential not taking adequate contraceptive
measures, or nursing; or a male intending to father children during the study.
2. Has significant gastrointestinal bleeding or any coagulopathy that would
contraindicate the use of anti-platelet therapy
3. Has known intolerance to study medications, paclitaxel or contrast agents that in the
opinion of the investigator cannot be adequately pre-treated.
4. Is currently participating in another investigational device or drug study that would
interfere with study endpoints.
5. Has history of hemorrhagic stroke within 3 months.
6. Has surgical or endovascular procedure of the target limb within 14 days prior to the
index procedure.
7. Has any planned surgical intervention (requiring hospitalization) or endovascular
procedure within 30 days after the index procedure.
8. Has had a previous peripheral bypass affecting the target limb.
9. Has unstable angina pectoris, myocardial infarction, liver failure, renal failure or
chronic kidney disease (dialysis dependent, or serum creatinine =2.5 mg/dL) within 30
days of the index procedure.
Cohort 1: Angiographic Exclusion Criteria:
1. Has significant stenosis (=50%) or occlusion of inflow tract that is not successfully
revascularized (<30% residual stenosis without death or major vascular complication)
prior to treatment of the target lesion(s). Only treatment of target lesion(s) is
acceptable after successful treatment of inflow iliac artery lesion(s).
2. Has an acute or sub-acute intraluminal thrombus within the target vessel.
3. Has in-stent restenosis or restenosis of the target lesion following previous
treatment with a drug-coated balloon.
4. Has an aneurysm (at least twice the reference vessel diameter) located in the target
vessel, abdominal aorta, iliac, or popliteal arteries.
5. Has perforation, dissection or other injury of the access or target vessel requiring
stenting or surgical intervention prior to enrollment.
6. Has no normal arterial segment proximal to the target lesion in which duplex
ultrasound velocity ratios can be measured.
7. Requires use of adjunctive therapies (i.e., laser, atherectomy, cryoplasty,
scoring/cutting balloons, brachytherapy).
8. Has severe calcification that precludes adequate PTA treatment.
Cohort 2: General Inclusion Criteria:
1. Has symptomatic leg ischemia, requiring treatment of the SFA and/or popliteal artery.
2. Has a Rutherford Clinical Category of 2 - 4. Note: Rutherford Clinical Category 2
subjects should be entered into the study if conservative treatment has been
unsuccessful.
3. Is between 18-85 years old.
4. Has life expectancy >1 year.
5. Is able and willing to provide written informed consent prior to study specific
procedures.
6. Is willing and capable of complying with the required follow-up visits, testing
schedule and medication regimen.
7. History of previous femoropopliteal nitinol stenting which is suspect for in-stent
restenosis.
8. The patient has a resting ankle-brachial index (ABI) <0.9 or an abnormal exercise ABI
(<0.9) if resting ABI is normal. Patient with incompressible arteries (ABI>1.2) must
have a toe-brachial index (TBI) <0.7 in target limb.
Cohort 2: Angiographic Inclusion Criteria:
1. Has angiographic evidence of significant restenosis (=50% by visual estimate) within a
previously deployed femoropopliteal bare nitinol stent(s) including ISR Class I, II or
III.
2. Has target limb with at least one patent (<50% stenosis) tibio-peroneal run-off vessel
to the foot confirmed by baseline angiography or magnetic resonance angiography (MRA)
or computed tomography angiography (CTA). Note: Treatment of outflow disease is NOT
permitted.
3. Total target treatment length of in-stent restenosis must be =4.0 cm in length and may
include a single lesion or a multifocal lesion within the femoropopliteal segment
(This includes the proximal, mid, and/or distal SFA and PI, P2 and/or P3 segment of
the popliteal artery). Edge restenosis may be treated provided the lesion extends no
more than 3 cm outside the margin of the stent (proximal and/or distal margin).
4. Has target lesion(s) located >2 cm from any stent if the target vessel was previously
stented.
5. Has a reference vessel diameter of 4 - 6 mm by visual estimate.
6. Has a successful exchangeable guidewire crossing of the lesion(s).
Cohort 2: General Exclusion Criteria:
1. A female who is pregnant, of childbearing potential not taking adequate contraceptive
measures, or nursing; or a male intending to father children during the study.
2. Has significant gastrointestinal bleeding or any coagulopathy that would
contraindicate the use of anti-platelet therapy.
3. Has known intolerance to study medications, paclitaxel or contrast agents that in the
opinion of the investigator cannot be adequately pre-treated.
4. Is currently participating in another investigational device or drug study that would
interfere with study endpoints.
5. Has history of hemorrhagic stroke within 3 months including those within <60 days with
an unresolved walking impairment.
6. Has surgical or endovascular procedure of the target limb within 3 months prior to the
index procedure.
7. Has any planned surgical intervention (requiring hospitalization) or endovascular
procedure within 30 days after the index procedure.
8. Has had a previous peripheral bypass affecting the target limb.
9. Has unstable angina pectoris, myocardial infarction within 60 days, liver failure,
renal failure or chronic kidney disease (dialysis dependent, or serum creatinine =2.5
mg/dL) within 30 days of the index procedure.
10. History of previous femoropopliteal stenting in the target lesion with drug eluting
stents or covered stents (endografts).
Cohort 2: Angiographic Exclusion Criteria:
1. Ipsilateral and/or contralateral iliac (or common femoral) artery stenosis
=50% diameter stenosis (DS) that is not successfully treated prior to index procedure
(e.g. where a perforation occurred requiring a covered stent) or with final residual
stenosis = 30% documented by angiography.
2. Identification of any lesion of the native vessel (excludes ISR) above the target
stent in the femoropopliteal segment >50% that is not successfully treated prior to
index procedure (e.g. complication requiring additional treatment) or with final
residual stenosis >30% documented by angiography. Drug eluting stent (DES) and drug
coated balloon (DCB) will not be allowed. The lesion length must be treatable with a
single stent (if required). The lesion must not be contiguous with the target lesion;
at least 2 cm of normal appearing vessel between the lesion and target lesion/ target
stent or between deployed stent (if required) and the target lesion/ target stent.
3. Has an acute or sub-acute intraluminal thrombus within the target vessel.
4. Has an aneurysm (at least twice the reference vessel diameter) located in the target
vessel, abdominal aorta, iliac, or popliteal arteries.
5. Has perforation, dissection or other injury of the access or target vessel requiring
stenting or surgical intervention prior to enrollment.
6. Has no normal arterial segment proximal to the target lesion in which duplex
ultrasound velocity ratios can be measured.
7. Requires use of adjunctive therapies (i.e., laser, atherectomy, cryoplasty,
scoring/cutting balloons, brachytherapy).
8. Grade 4 or 5 stent fracture affecting target stent or proximal to the target stent, or
where evidence of stent protrusion into the lumen is noted on angiography in 2
orthogonal views.
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