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:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-26 @ 10:56 AM
NCT ID:
NCT01575808
Eligibility Criteria:
Inclusion Criteria:
* Rutherford 2-5 category
* Subject has read, understood and signed written informed consent which has been reviewed and approved by the Institutional Review Board (IRB).
* At least 20 years of age.
* Ankle-brachial index (ABI) in the study limb in the non-invasive lower extremity arterial studies within 30 days prior to study procedure or at the time of study procedure is less than or equal to 0.9, or toe-brachial index (TBI) is less than or equal to 0.5.
* Male, infertile female, or female of child-bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7 days prior to study procedure.
* Projected life expectancy of greater than 2 years.
* The ability to comply with the study protocol, follow-up requirements and required testing.
* Surgical bypass candidate
* Qualifying lesions by angiography
Exclusion Criteria:
* Untreated flow-limiting aortoiliac disease.
* Any previous stenting or surgery in the target vessel(i.e. femoro-popliteal artery).
* Vascular access/catheterization in the target or contralateral limb within 30 days of study enrollment.
* Planned surgery or intervention within 30 days after study procedure.
* Femoral artery or popliteal artery aneurysm \> 1.5 X healthy adjacent vessel diameter.
* Non-atherosclerotic disease resulting in stenosis and/or occlusion (e.g., embolism, Buerger's disease, vasculitis).
* Severe medical comorbidities (untreated CAD/CHF (Congestive Heart Failure), severe COPD (Chronic Obstructive Pulmonary Disease), severe dementia, NYHA (New York Heart Association) 3/4, severe hypertension, etc.)
* Any medical condition that would preclude post-procedural ambulation or completion of study follow-up.
* Rutherford 5 patients with active infection.
* Serum creatinine \>2.5 mg/dL within 30 days prior to study procedure.
* Rutherford 6 category in the study or non-study limb or major tissue loss extending above the proximal phalanx level.
* Rutherford 5 characteristics in non-study limb.
* Major distal amputation (above the transmetatarsal) in the study or non-study limb.
* Active infection that could adversely impact patient outcomes in the study, or any patient with septicemia or bacteremia.
* Any previously known coagulation disorder, including hypercoagulability.
* Morbid obesity or operative scarring that precludes percutaneous approach
* Contraindication to anticoagulation or antiplatelet
* Known allergies to stent/stent-graft components, including heparin sensitivity, allergy, or previous incidence of heparin-induced thrombocytopenia (HIT) type II.
* Current peritoneal or hemodialysis
* Participation in another clinical trial (except F/P device clinical trial) up to 3 months prior to study enrollment.
* Enrollment in a F/P device clinical trial within the last 12 months.
* Interventional or surgical treatment on arteries distal to the target vessel for this study within the past 12 months.
* Any other factor identified by the Principal Investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01575808
Study Brief:
Protocol Section:
NCT01575808