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:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
NCT ID:
NCT01816412
Eligibility Criteria:
Inclusion Criteria:
* Male or non-pregnant female ≥20 years of age;
* Rutherford Clinical Category 2-4;
* Length ≤15 cm;
* ≥70% stenosis
* Lesion location starts ≥1 cm below the common femoral bifurcation and terminates distally ≤2 cm below the tibial plateau AND ≥1 cm above the origin of the TP trunk;
* A patent inflow artery as confirmed by angiography
* At least one patent native outflow artery to the ankle
Exclusion Criteria:
* Life expectancy of \< 2 years;
* History of hemorrhagic stroke within 3 months;
* Previous or planned surgical or interventional procedure within 2 weeks before or within 30 days after the index procedure;
* History of MI, thrombolysis or angina within 2 weeks of enrollment;
* Renal failure or chronic kidney disease
* Severe calcification that renders the lesion un-dilatable
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
100 Years
Study:
NCT01816412
Study Brief:
Protocol Section:
NCT01816412