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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT04966767
Eligibility Criteria:
Inclusion Criteria:
* Rutherford classification of 3-6
* Willing to comply with all follow-up evaluations at the specified times
* Target lesion(s) located within the native infrarenal abdominal aorta and/or common iliac artery and/or external iliac artery
* Evidence of ≥ 50% stenosis, restenosis (from PTA or adjunct therapy, not including stents or stent grafts), or occlusion of target lesion(s), or arterial thrombosis underwent PMT or CDT
* Provides written informed consent
Exclusion Criteria:
* Contraindication or known untreatable allergy to antiplatelet therapy, anticoagulants, thrombolytic drugs, or any other drug used during the study
* Known hypersensitivity to contrast material that cannot be adequately pretreated
* Bleeding diathesis or coagulopathy, known hypercoagulable condition or refuses blood transfusion
* Female currently breastfeeding, pregnant, or of childbearing potential not using adequate contraceptive measures
* Life expectancy less than 24 months
* Current participation in an investigational drug or other device study
* Severe comorbid conditions
* Myocardial infarction or stroke within 3 months prior to enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04966767
Study Brief:
Protocol Section:
NCT04966767