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:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT03129750
Eligibility Criteria:
Inclusion Criteria:
1. Documented obstructive ischemic, symptomatic arterial disease in the femoral-popliteal arteries according to Rutherford Category 2, 3 or 4
2. Target lesion consists of a single solitary or multiple adjacent de novo or re-stenotic lesions (non-in-stent) with diameter stenosis ≥ 70% by visual estimate and cumulative lesion length ≥ 15 cm
3. Target vessel is the superficial femoral artery and/or popliteal artery (P1-2-3)
4. Life expectancy \>1 year in the Investigator's opinion
5. Written informed consent
Exclusion Criteria:
1. Patient unwilling or unlikely to comply with FU schedule
2. Administration of local or systemic thrombolytic therapy within 48 hours prior to the index procedure
3. Known allergies or sensitivities to heparin, aspirin, other anticoagulant/antiplatelet therapies, and/or paclitaxel
4. Additional planned cardiac or peripheral percutaneous or surgical intervention including CABG within 30 days following the study procedure
5. ≥15 cm long inflow lesion (≥50% DS)
6. Failure to successfully treat \< 15 cm long inflow lesion in the ipsilateral Iliac artery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03129750
Study Brief:
Protocol Section:
NCT03129750