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 @ 9:15 PM
Ignite Modification Date:
2025-12-24 @ 9:15 PM
NCT ID:
NCT03517904
Eligibility Criteria:
Inclusion Criteria:
* Age 19 years or older
* Symptomatic peripheral artery disease:
* Moderate or severe claudication (Rutherford category 2 or 3)
* Critical limb ischemia (Rutherford category 4 or 5)
* Femoropopliteal artery disease (stenosis \> 50%)
* ABI \<0.9
* Patients with signed informed consent
Exclusion Criteria:
* Acute critical limb ischemia
* Severe critical limb ischemia (Rutherford category 6)
* Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, cilostazol, or contrast agents
* Patients requiring oral anticoagulation using warfarin or NOAC
* Age \> 85 years
* Severe hepatic dysfunction (\> 3 times normal reference values)
* Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
* LVEF \< 40% or clinically overt congestive heart failure
* Pregnant women or women with potential childbearing
* Life expectancy \<1 year due to comorbidity
* Previous bypass surgery or stenting in the target femoropopliteal artery
* Untreated inflow disease of the ipsilateral pelvic or femoropopliteal arteries (more than 50% stenosis or occlusion)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
85 Years
Study:
NCT03517904
Study Brief:
Protocol Section:
NCT03517904