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 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT00180505
Eligibility Criteria:
Inclusion Criteria:
* De novo lesion of the superficial femoral artery (SFA) or proximal popliteal artery within the following parameters:
* 10 mm distal to the origin of the profunda femoris (= 10 mm from the femoral bifurcation in the SFA) and
* 20 mm from the proximal margin of the intercondylar fossa.
* Patients must have symptomatic leg ischemia, requiring treatment of the superficial femoral/proximal popliteal vessel
* Target vessel reference diameter visually estimated to be \> 4.0 mm and \< 7.0 mm
* Target lesion length visually estimated to be \> 40 mm and \< 200 mm
* If the patient has a contralateral SFA or contralateral proximal popliteal lesion, this lesion can be treated as a non-target lesion. The time and way of treatment of the non-target lesion will be left up to the discretion of the investigator
* At least one-vessel run-off to the foot confirmed by baseline angiography
* Patent common iliac artery, common femoral artery and profunda confirmed by baseline angiography. The patent common iliac artery can be obtained during the index procedure by a successful treatment prior to the treatment of the target lesion. Successful treatment being defined as attainment of final residual diameter stenosis of \< 30% without death, stroke, bleeding requiring \> 2 units transfusion, or any other complication which was device or procedure related.
* Patient is acceptable candidate for femoral-popliteal artery bypass surgery
Exclusion Criteria:
* Previous ipsilateral femoro-popliteal or femoro-tibial surgery
* Presence of a stent in the target vessel
* Prescheduled staged procedures of multiple lesions within the ipsilateral iliac or ipsilateral popliteal arteries within 30 days after the index procedure
* Co-existing aneurysmal disease of the abdominal aorta or iliac or popliteal arteries
* Acute thrombophlebitis or deep vein thrombus
* Any immunosuppressive disorders, groin infection, or acute systemic infection due to any cause or any viral or bacterial infection
* Significant gastrointestinal (GI) bleed within the past month that would contraindicate the use of anti-platelet therapy
* Hemodynamic instability
* Target lesion is restenotic from previous intervention
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00180505
Study Brief:
Protocol Section:
NCT00180505