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 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT01420120
Eligibility Criteria:
Inclusion Criteria:
* Patients with symptomatic leg ischemia requiring treatment of SFA artery or proximal popliteal artery located within the following parameters:
* 1 cm from the femoral bifurcation in the SFA
* 3 cm from the proximal margin of the intercondylar fossa
* Rutherford-Becker Category 2-5. In patients with bilateral lesions, the highest Rutherford Category limb should be treated. Only 1 leg can be included.
* Single lesion which can be covered by one stent.
* Target vessel reference diameter ≥ 4 mm and ≤ 6 mm (by visual estimate)
* A patent popliteal artery free from significant stenosis (\>50%) with at least one patent vessel runoff as confirmed by baseline angiography
* Signed informed consent.
Exclusion Criteria:
* Pregnancy
* Previous stenting of target lesion
* Acute ischemia
* Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion). Inclusion of a patient is allowed in case inflow lesions are successfully treated during the index-procedure yielding less than 30% diameter stenosis.
* Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy
* Known intolerance to study medications or contrast agents.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01420120
Study Brief:
Protocol Section:
NCT01420120