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 @ 3:54 PM
Ignite Modification Date:
2025-12-24 @ 3:54 PM
NCT ID:
NCT02793492
Eligibility Criteria:
Inclusion Criteria:
1. Is ≥ 18 years old and of legal consent.
2. Is willing to comply with all follow-up evaluations at the specified times.
3. Subject or subject's legal representative has been informed of and understands the nature of the study and provides signed informed consent to participate in the study.
4. Has a Rutherford Clinical Category Score of 2, 3 or 4.
5. Radiographic evidence of ≥ 50% stenosis or restenosis (from PTA or adjunct therapy, not including stents or stent grafts), or occlusion of target lesion(s) in the common iliac artery and/or external iliac artery.
Exclusion Criteria:
1. Has had previous stent or stent-graft implantation in the target lesion(s).
2. Has a contraindication or known untreatable allergy to antiplatelet therapy, anticoagulants, thrombolytic drugs or any other drug used during the study according to the protocol.
3. Has known hypersensitivity to contrast material that cannot be adequately pretreated.
4. Has known hypersensitivity to nickel-titanium (nitinol).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02793492
Study Brief:
Protocol Section:
NCT02793492