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 @ 7:36 PM
Ignite Modification Date:
2025-12-24 @ 7:36 PM
NCT ID:
NCT02907203
Eligibility Criteria:
Inclusion Criteria:
* PAD patients with Rutherford Class 2 - 4
* De novo or restenotic lesions, including total occlusions of the SFA/PA
* 1 lesion which may include one or more regions of luminal narrowing ≥70% with a total combined lesion length between 30 - 150mm and a reference vessel diameter of 4 - 6mm
* 1 patent tibial or peroneal artery
Exclusion Criteria:
* Surgical or endovascular access in the Target limb/vessel within the previous 30 days
* Prior treatment of the Target lesion with PTA within 90 days or any prior treatment with drug-coated balloon
* Prior treatment of the Target vessel with stenting or bypass
* Iliac artery inflow lesions that cannot be successfully treated during the Index procedure
* Acute or subacute thrombus or arterial aneurysm in Target limb
* Severe calcification that renders the Target lesion non-dilatable
* Acute or chronic renal dysfunction (serum creatinine ≥2.5 mg/dL)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT02907203
Study Brief:
Protocol Section:
NCT02907203