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 @ 12:47 PM
Ignite Modification Date:
2025-12-24 @ 12:47 PM
NCT ID:
NCT01566461
Eligibility Criteria:
Inclusion Criteria:
* Age: \> or equal to 18 years and \< or equal to 85 years
* Documented ischemia with Rutherford classification 2, 3, or 4
* Target lesion in the SFA and/or PPA
* Angiographic evidence that target lesion consists of a single de novo or non-stented restenotic lesion or is a combination lesion that meets the following criteria:
1. 70 - 99% occlusion by visual estimate with lesion length \> or equal to 4 cm and \< or equal to 18 cm
2. 100% occlusion by visual estimate with lesion length \< or equal to 10 cm
3. Combination lesions must have a total lesion length of \> or equal to 4 cm and \< or equal to 18 cm with an occluded segment that is \< or equal to 10 cm (by visual estimate)
* Target vessel diameter \> or equal to 4 mm and \< or equal to 7 mm
* Angiographic evidence of adequate distal run-off to the ankle
* Able to walk without assistive devices
Exclusion Criteria:
* Stroke or heart attack within 3 months prior to enrollment
* Enrolled in another investigational drug, device or biologic study
* Any surgical procedure or intervention performed within 30 days prior to or post index procedure
* SFA or PPA disease in the opposite leg that requires treatment at the index procedure
* Failure to successfully cross the target lesion
* Angiographic evidence of severe calcification
* Target lesion requires treatment with alternative therapies such as stenting, laser, atherectomy, cryoplasty, brachytherapy, re-entry devices)
* Known allergies or sensitivity to heparin, aspirin, other anticoagulant/antiplatelet therapies, paclitaxel or contrast media that cannot be adequately pre-treated prior to index procedure
* Chronic kidney disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01566461
Study Brief:
Protocol Section:
NCT01566461