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 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT05459818
Eligibility Criteria:
Inclusion Criteria:
1. Patient was enrolled and treated with the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface device in a Gore-sponsored or physician-sponsored study for de novo or restenotic lesions of the femoropopliteal artery.
2. Lesions ≥10 cm in length and TASC C or D classification will be included
3. Patient-level data can be obtained and pooled with other studies
Exclusion Criteria:
1. Patient was not formally enrolled in their corresponding study (e.g., training cases)
2. Patient was enrolled for treatment of in-stent restenotic lesions.
3. Patient has incomplete or missing data that does not allow for analysis.
4. Case reports (n\<10 patients)
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT05459818
Study Brief:
Protocol Section:
NCT05459818