Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-25 @ 3:25 AM
NCT ID:
NCT02400905
Eligibility Criteria:
Inclusion Criteria:
* Symptomatic peripheral arterial disease (PAD) of the lower extremities requiring intervention to relieve de novo obstruction or occlusion of the native femoropopliteal artery.
* PAD classified as Rutherford clinical category 2, 3 or 4.
* Resting ankle-brachial index (ABI) of ≤0.90 (or ≤0.75 after exercise of the target limb) or angiographic or DUS evidence of \>/= 60%.
* Single or multiple stenotic or occlusive lesions within the native femoropopliteal artery ("target lesions") that can be crossed with a guidewire and fully dilated.
* Single or multiple target lesions must be covered by a single stent or two overlapping stents.
* Target lesion(s) eligible for treatment at least 1 cm distal to the origin of the deep femoral artery and at least 3 cm above the bottom of the femur.
* Target lesion(s) reference vessel diameter is between 4.0 mm and 6.0 mm.
* Single or multiple target lesions measure ≥40 mm to ≤140 mm in overall length, with ≥60% diameter stenosis by operator's visual estimate.
* Patent popliteal artery (no stenosis ≥50%) distal to the treated segment.
* At least one patent infrapopliteal vessel (\<50% stenosis) with run-off to the ankle.
Exclusion Criteria:
* Iliac stent in target limb that has required re-intervention within 12 months prior to index.
* Target vessel that has been treated with bypass surgery.
* PAD classified as Rutherford clinical category 0, 1, 5 or 6.
* Known coagulopathy or has bleeding diatheses, thrombocytopenia with platelet count less than 100,000/microliter or INR \>1.8.
* Stroke diagnosis within 3 months prior to enrollment.
* History of unstable angina or myocardial infarction within 60 days prior to enrollment.
* Thrombolysis within 72 hours prior to the index procedure.
* Acute or chronic renal disease (e.g., as measured by a serum creatinine of \>2.5 mg/dL or \>220 umol/L), or on peritoneal or hemodialysis.
* Significant disease or obstruction (≥50%) of the inflow tract that has not been successfully treated at the time of the index procedure (success measured as ≤30% residual stenosis, without complication).
* No patent (≥50% stenosis) outflow vessel providing run-off to the ankle.
* Target lesion(s) requires percutaneous interventional treatment, beyond standard balloon angioplasty alone, prior to placement of the study stent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
85 Years
Study:
NCT02400905
Study Brief:
Protocol Section:
NCT02400905