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 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT02698358
Eligibility Criteria:
Inclusion Criteria:
1. Age 19 years of older
2. Symptomatic peripheral artery disease:
* Moderate or severe claudication (Rutherford category 2 or 3)
* Critical limb ischemia (Rutherford category 4)
3. Iliac artery lesions with stenosis \> 50%
4. ABI \<0.9
5. Patients with signed informed consent
Exclusion Criteria:
1. Acute critical limb ischemia
2. Severe critical limb ischemia (Rutherford category 5 or 6)
3. Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, cilostazol, or contrast agents
4. In-stent restenosis lesions (Restenosis lesions without previously implanted stents are eligible to the enrollment)
5. Bypass graft lesions
6. Age \> 85 years
7. Severe hepatic dysfunction (\> 3 times normal reference values)
8. Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
9. LVEF \< 40% or clinically overt congestive heart failure
10. Pregnant women or women with potential childbearing
11. Life expectancy \<1 year due to comorbidity
12. Untreated proximal inflow disease of aorta or the ipsilateral iliac arteries (more than 50% stenosis or occlusion)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
85 Years
Study:
NCT02698358
Study Brief:
Protocol Section:
NCT02698358