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 @ 7:32 PM
Ignite Modification Date:
2025-12-24 @ 7:32 PM
NCT ID:
NCT01570803
Eligibility Criteria:
Inclusion Criteria:
* Clinical criteria
1. Age 20 years of older
2. Symptomatic peripheral-artery disease with (Rutherford 2 - 6); moderate to severe claudication (Rutherford 2-3), chronic critical limb ischemia with pain while was at rest (Rutherford 4), or with ischemic ulcers (Rutherford 5-6)
3. Patients with signed informed consent
* Anatomical criteria
1. Stenosis of \>50% or occlusive atherosclerotic lesion of the ipsilateral femoropopliteal artery
2. Patent (≤50% stenosis) ipsilateral iliac artery or concomitantly treatable ipsilateral iliac lesions (≤30% residual stenosis),
3. At least one patent (less than 50% stenosed) tibioperoneal run-off vessel.
Exclusion Criteria:
1. Disagree with written informed consent
2. Major bleeding history within prior 2 months
3. Known hypersensitivity or contraindication to any of the following medication: heparin, aspirin, clopidogrel, cilostazol, or contrast agent
4. Acute limb ischemia
5. Previous bypass surgery or stenting of the ipsilateral femoropopliteal artery
6. Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion)
7. Patients that major amputation ("above the ankle" amputation) has been done, is planned or required
8. Patients with life expectancy \<1 year due to comorbidity
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
90 Years
Study:
NCT01570803
Study Brief:
Protocol Section:
NCT01570803