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 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT03452293
Eligibility Criteria:
Inclusion Criteria:
General Inclusion Criteria:
* Patients with CLI and TASC C-D Fem-Pop CTO's
* Age ≥18 years
* Patient has signed an approved consent form
* Patients without previous stenting of the Fem-Pop segment
Angiographic Inclusion Criteria:
* Patent and hemodynamically normal iliac and common femoral arteries.
* At least one patent and healthy tibial vessel runoff to the foot.
* Patient has documented TASC C or D Fem-Pop CTO's prior to the study procedure
* Rutherford Category 4, 5 or 6
* Subintimal crossing of the occluded Fem-Pop vessels
* Supera Stenting From healthy to healthy arterial segment.
Exclusion Criteria:
* Patient unwilling or unlikely to comply with Follow-Up schedule
* Endoluminal crossing of the CTO
* Inability to stent from "healthy to healthy" arterial segments.
* Inability to re-enter within the pre-specified Ideal Landing Zone (IDL)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03452293
Study Brief:
Protocol Section:
NCT03452293