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 @ 7:07 PM
Ignite Modification Date:
2025-12-24 @ 7:07 PM
NCT ID:
NCT01952457
Eligibility Criteria:
Inclusion Criteria:
* Patient presenting with lifestyle-limiting claudication, rest pain or minor tissue loss (Rutherford classification from 2 to 5)
* Patient is willing to comply with specified follow-up evaluations at the specified times
* Patient is \>18 years old
* Patient understands the nature of the procedure and provides written informed consent, prior to enrollment in the study
* Patient has a projected life-expectancy of at least 24 months
* Noninvasive lower extremity arterial studies (resting or exercise) demonstrate ankle-brachial index ≤0.8
* Patient is eligible for treatment with the Zilver PTX paclitaxel-eluting stent (Cook) or with surgical bypass placement
* 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
* Stenotic or occlusive de novo lesion located in the femoropopliteal arteries, suitable for endovascular therapy and for bypass surgery
* Total target lesion length is at least 15cm
* Minimum of 1.0cm of healthy vessel (non-stenotic) both proximal and distal to the treatment area
* P2 and P3 are patent and there is angiographic evidence of at least one vessel-runoff to the foot, that does not require intervention (\<50% stenotic)
* Target vessel diameter visually estimated to be \>4mm and \<9mm at the proximal and distal treatment segments within the SFA
Exclusion Criteria:
* Untreated flow-limiting aortoiliac stenotic disease
* Any previous surgery and/or endovascular procedure in the target vessel
* Severe ipsilateral common/deep femoral disease requiring surgical reintervention
* Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment
* Femoral or popliteal aneurysm located at the target vessel
* Non-atherosclerotic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
* No patent tibial arteries (\>50% stenosis)
* Prior ipsilateral femoral artery bypass
* Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic malignancy, dementia, etc.) or other medical condition that would preclude compliance with the study protocol or 2-year life expectancy
* Serum creatinine \>2.5mg/dL within 45 prior to study procedure unless the subject is currently on dialysis
* Major distal amputation (above the transmetatarsal) in the study or non-study limb
* Any previously known coagulation disorder, including hypercoagulability
* Contraindication to anticoagulation or antiplatelet therapy
* Known allergies to stent or bypass graft components (nickel-titanium, Dacron, ePTFE, etc.)
* Known allergy to contrast media that cannot be adequately pre-medicated prior to the study procedure
* Currently participating in another clinical research trial
* Angiographic evidence of intra-arterial thrombus or atheroembolism from inflow treatment
* Any planned surgical intervention/procedure within 30 days of the study procedure
* Target lesion access in the Zilver PTX stent arm not performed by transfemoral approach
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01952457
Study Brief:
Protocol Section:
NCT01952457