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 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT07277218
Eligibility Criteria:
Inclusion Criteria:
* (1) Age \> 18 years. (2) Willing and able to provide informed consent. (3) Rutherford Clinical Category 2-5. (4) Presence of ≥50% stenosis and/or occlusion (\>30 days post-implantation) in a superficial femoral artery stent, located from at least 1cm distal to the origin of the profunda femoris artery to at least 1cm proximal to the femoral intercondylar notch.
(5) The target lesion must be within the stented segment or extend no more than 3cm proximal or distal to the stent.
(6) Planned treatment with either a DCB (with provisional BMS stenting) or a DES.
(7) Total target lesion length ≤30 cm. (8) At least one patent runoff vessel below the knee. (9) Patient is committed to participate in follow-up visits at 1, 3, 6, 12, and 24 months.
Exclusion Criteria:
* (1) Pregnancy or lactation. (2) Rutherford Category 0 or 6. (3) Severe calcification of the target lesion precluding PTA. (4) Acute ischemia and/or acute thrombosis in the target limb. (5) Untreated hemodynamically significant aorto-iliac stenotic disease. (6) Target lesion stenosis \<50%. (7) Target lesion length \>30 cm. (8) History of cerebrovascular accident within 60 days prior to the procedure. (9) Contraindication to antiplatelet, anticoagulant, or thrombolytic therapy. (10) Inability or unwillingness to provide informed consent. (11) Life expectancy of less than 2 years or other factors making follow-up unlikely.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT07277218
Study Brief:
Protocol Section:
NCT07277218