None listed
Conditions
Brief summary
Single-Arm Multicenter Study to continue to assess the safety and performance of the CVI Paclitaxel-Coated PTA Balloon Catheter in the treatment of de novo or restenotic lesions in the superficial femoral and/or popliteal arteries.
Interventions
Percutaneous Transluminal Angioplasty will be completed using a 2.0 micrograms per square millimeter. Paclitaxel-Coated Balloon. Balloon will be inflated to a size appropriate for the target vessel, as determined by the physician. Total balloon inflation time is determined by the physician, but no less than one minute.
Sponsors
Covidien
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria 1. Has clinically significant 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 2-3 subjects should be entered into the study if conservative treatment and/or medicinal therapy have been unsuccessful. 3. Is at least 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. 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, 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 length of no more than 20 cm. 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. 6. Has a successful exchangeable guidewire crossing of the lesion(s).
Exclusion criteria
General Exclusion Criteria 1. Is pregnant, of childbearing potential not taking adequate contraceptive measures, or nursing. 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 within 30 days of the index procedure. Angiographic Exclusion Criteria 1. Has significant stenosis (greater than or equal to 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). Treatment of target lesion(s) is acceptable after successful treatment of inflow 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 aneurysmal target vessel. 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.
Outcome results
None listed