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 @ 1:36 PM
Ignite Modification Date:
2025-12-24 @ 1:36 PM
NCT ID:
NCT01834495
Eligibility Criteria:
Inclusion Criteria:
1.Clinical criteria:
1. symptomatic peripheral-artery disease with
* moderate to severe claudication (Rutherford 2-3),
* chronic critical limb ischemia with pain while was at rest (Rutherford 4),
* or chronic critical limb ischemia with ischemic ulcers (Rutherford 5-6)
2. Patients with signed informed consent
2\. Anatomical criteria:
1. Target lesion length ≥ 4 cm by angiographic estimation,
2. Stenosis of more than 50% or occlusion of the ipsilateral iliac artery,
3. Patent (≤50% stenosis) ipsilateral femoropopliteal artery or concomitantly treatable ipsilateral femoropopliteal lesions (≤30% residual stenosis),
4. At least one patent (less than 50% stenosed) tibioperoneal runoff 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 medications: heparin, aspirin, clopidogrel or contrast agent
4. Acute limb ischemia
5. Untreated inflow disease of the distal aorta (more than 50 percent stenosis or occlusion)
6. Patients that major amputation ("above the ankle" amputation) has been done, is planned or required
7. Patients with life expectancy \<1 year due to comorbidity
8. Age \> 85 years
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
85 Years
Study:
NCT01834495
Study Brief:
Protocol Section:
NCT01834495