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 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT01817660
Eligibility Criteria:
Inclusion Criteria:
1. Age \> 35 years
2. Popliteal artery aneurysm \> 2 cm in diameter with or without presence of mural thrombus
3. Candidate for either OPAR or EPAR as judged by the treating investigator.
4. Greater than 2 cm length of normal superficial femoral artery distal to the deep femoral artery takeoff and \>2 cm length of normal popliteal artery proximal to the first patent tibial artery.
5. Willing to comply with protocol, attend follow-up appointments, complete all study assessments, and provide written informed consent.
Exclusion Criteria:
1. Popliteal artery thrombosis
2. Popliteal artery aneurysm causing symptomatic thromboembolic disease or compressive symptoms.
3. Superficial femoral artery occlusion or distal tibio-peritoneal occlusion
4. Less than 2 cm length of normal artery to accommodate stent graft seal
5. Life expectancy of less than 2 years.
6. Deemed excessive risk for surgical bypass (defined as prohibitive operative risk by formal pre-procedural cardiac risk assessment undertaken by a cardiologist or internist according to established AHA guideline criteria).
7. A documented hypercoagulable state (defined as a known blood disorder associated with venous or arterial thrombosis).
8. Any infrainguinal revascularization procedure on index leg within 12 weeks prior to treatment initiation.
9. Current immune-suppressive medication, chemotherapy or radiation therapy.
10. Absolute contraindication to iodinated contrast due to prior near-fatal anaphylactoid reaction (laryngospasm, bronchospasm, cardiorespiratory collapse, or equivalent) and which would preclude patient from participation in angiographic procedures.
11. Allergy to stainless steel or nitinol.
12. Pregnancy or lactation.
13. Inability or refusal to provide informed consent.
14. Patients who received an investigational drug for peripheral arterial disease within 4 weeks of screening or who participated in another non-observational clinical trial in the prior 30 days.
15. Prior leg bypass on the ipsilateral limb
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Study:
NCT01817660
Study Brief:
Protocol Section:
NCT01817660