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 @ 11:30 PM
Ignite Modification Date:
2025-12-24 @ 11:30 PM
NCT ID:
NCT02653456
Eligibility Criteria:
Inclusion Criteria:
* signed informed consent
* symptomatic infrainguinal lower extremity vascular disease (Rutherford category 3, 4, 5 or 6), stable for at least 2 weeks prior to study inclusion
* lesions in the superficial femoral artery (SFA), popliteal, or infrapopliteal arteries at least one angiographically identifiable infrageniculate artery
* patients must be poor surgical candidates, indicated by at least one of the following conditions:
* absence of venous autologous grafts (that is, lack of a suitable vein to use for bypass)
* poor (diffusely diseased or \<=1mm diameter) or no distal vessels available for graft anastamosis
* high risk of surgical mortality, evidenced by American Society of Anesthesiologists Physical Class 4 or higher
Exclusion Criteria:
* age below 18 years
* pregnancy, or plan to become pregnant
* participation in another cardiovascular or peripheral vascular study
* myocardial infarction (MI) in prior month
* stents at treatment site
* disorders or allergies precluding use of radiographic contrast
* renal insufficiency sever enough to contraindicate use of radiographic contrast
* contraindication to treatment with anticoagulants
* untreated ipsilateral iliac stenosis \>70%
* inability or unwillingness of the patient to comply with intended examinations
* unavailability of required procedural or imaging equipment
* lesion located in a graft
* hemodynamically significant arrhythmia or left ventricular ejection fraction \<20%
* life expectancy less than 6 months
* necrosis necessitating major amputation
* unwillingness of the patient to be anti-coagulated
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02653456
Study Brief:
Protocol Section:
NCT02653456