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 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT02961894
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years;
2. Willing and able to provide informed consent.
3. Ability to take at least one form of anti-platelet therapy.
4. Rutherford categories 2 to 5 in the target limb.
5. Lesions to be treated with the study device must be located in the same limb.
6. Target lesion(s) located within the superficial femoral, popliteal or tibial arteries.
7. Target lesion(s) with stenosis ≥70% diameter reduction as measured by site-reported angiography.
8. Target lesion length(s) ≤150 mm.
9. Target lesions(s) with reference vessel diameter (proximal and distal to target lesion) ≥2.0 mm and ≤4.0 mm.
Exclusion Criteria:
1. Subjects in whom amputation above the ankle is necessary, irrespective of the success of revascularization.
2. In-stent restenosis within the target lesion.
3. Flow-limiting dissection, Type C or greater.
4. Target lesions within an autogenous or prosthetic bypass graft.
5. History of an endovascular procedure or open vascular reconstruction in the index limb within the last 30 days, including thrombolytic therapy.
6. Any open vascular surgical procedure planned in the target limb or endovascular procedures planned in the target vessel within 30 days after the index procedure.
7. Kidney disease of sufficient severity, in the Investigator's opinion, to contraindicate lower extremity angiography using standard or alternate contrast agents as per the local Standard of Care.
8. Pregnancy or breast feeding. A woman of child-bearing potential must have a negative pregnancy test within one week of index procedure.
9. Myocardial infarction or stroke within 2 months of enrollment.
10. Contraindication to antiplatelet, anticoagulant, or thrombolytic therapy.
11. Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count \< 125,000/μL, known coagulopathy, or INR \> 1.5.
12. Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pretreated in the opinion of the investigator.
13. History of heparin-induced thrombocytopenia.
14. Psychiatric disorder which, according to the investigator, has potential to interfere with provision of informed consent, completion of tests, therapy, or follow-up.
15. Clinical/angiographic evidence of distal embolization or acute thrombus.
16. Significant stenosis (\>50% diameter reduction) or occlusion of inflow vessels that was not successfully treated (\<50% residual stenosis without flow limiting dissection) before the study intervention.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02961894
Study Brief:
Protocol Section:
NCT02961894