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 @ 5:07 AM
Ignite Modification Date:
2025-12-25 @ 5:07 AM
NCT ID:
NCT02517827
Eligibility Criteria:
Inclusion Criteria:
1. Subject must be between 21 and 85 years old;
2. Female of childbearing potential must have a negative pregnancy test within 10 days prior to index procedure and utilize reliable birth control until completion of the 12-month angiographic evaluation;
3. Clinical diagnosis of symptomatic peripheral artery disease defined by Rutherford 2, 3, or 4;
4. Common femoral artery (CFA) stenosis (including CFA bifurcation) \>70% (visual estimate) or occlusion; Additional non-target lesion(s) in remaining non-target vessel(s), except ipsilateral iliac arteries, can be treated at the physician´s discretion;
5. At least one vessel outflow (infrapopliteal arteries) to the foot (without stenosis \>50%).
6. Endovascular Procedure: successful target lesion crossing of the guidewire (guidewire located intraluminally);
7. Non-target lesion interventions (TASC A and B) to restore adequate blood flow, in the same index procedure are allowed. This intervention must be prior to the treatment of the study lesion and successful;
8. Willing to comply with the specified follow-up evaluation;
9. Written informed consent prior to any study procedures.
Exclusion Criteria:
1. Ipsilateral significant (\>50%) stenosis of the iliac arteries.
2. Significant (\>50%) stenosis of all infrapopliteal arteries, no patent artery to the foot.
3. Angiographic evidence of thrombus within target vessel;
4. Thrombolysis within 72 hours prior to the index procedure;
5. In-Stent restenosis or restenosis of the native common femoral artery.
6. Aneurysm in the abdominal aorta or iliac arteries;
7. Concomitant hepatic insufficiency, thrombophlebitis, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy;
8. Recent MI or stroke \< 30 days prior to the index procedure;
9. Life expectancy less than 24 months;
10. Known or suspected active infection at the time of the index procedure;
11. Known or suspected allergies or contraindications to aspirin, clopidogrel bisulfate (Plavix) and ticlopidine (Ticlid), heparin, or contrast agent;
12. Any significant medical condition which, in the investigator´s opinion, may interfere with the subject´s optimal participation in the study;
13. The subject is currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
85 Years
Study:
NCT02517827
Study Brief:
Protocol Section:
NCT02517827