GORE VIABAHN Endoprosthesis Versus Bare Nitinol Stent in the Treatment of Long Lesion (>8cm) Superficial Femoral Artery Occlusive Disease
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Peripheral Vascular Diseases
- Sponsor
- W.L.Gore & Associates
- Enrollment
- 148
- Locations
- 15
- Primary Endpoint
- Efficacy: Primary Patency at Three Years
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
To evaluate the performance of the GORE VIABAHN® Endoprosthesis compared to a bare nitinol stent for the treatment of superficial femoral artery (SFA) occlusive disease in long lesions.
Detailed Description
This is a multicenter, prospective, randomized study with clinical and radiographic follow-up for three years post-procedure. Approximately one hundred fifty subjects will be enrolled and randomized into one of two study treatment groups.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Lifestyle-limiting claudication or rest pain.
- •Subject (or their legal guardian) has read, understood and provided written informed consent.
- •At least 21 years of age.
- •Quality of life questionnaires completed.
- •Noninvasive lower extremity arterial studies within 45-days prior to study procedure.
- •If applicable, staged ipsilateral vascular procedure ≥ 14-days prior to study procedure.
- •If applicable, vascular treatment on non-study leg for bilateral claudication ≥ 14-days prior to study procedure.
- •Male, infertile female, or female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test.
- •Projected life expectancy of greater than three years.
- •The ability to comply with protocol.
Exclusion Criteria
- •Untreated flow-limiting aortoiliac occlusive disease.
- •Any previous stenting or surgery in the target vessel.
- •Subjects with arterial lesions requiring treatment with device diameters other than 6, 7, or 8 mm.
- •Severe ipsilateral common femoral/profunda disease requiring surgical intervention.
- •Femoral or popliteal aneurysm.
- •Non-atherosclerotic disease resulting in occlusion.
- •Tibial artery disease requiring treatment.
- •Prior ipsilateral femoral artery bypass.
- •Severe medical comorbidities.
- •Popliteal artery vascular access at any time during procedure.
Outcomes
Primary Outcomes
Efficacy: Primary Patency at Three Years
Time Frame: 3 years
Primary patency is the Peak Systolic Velocity Ratio (PSVR) maintained at or below 2.0 without any repeat intervention. The PSVR is the ratio of the highest velocity (or pressure) of the blood moving through the stent divided by the velocity immediately outside the stent (the end of the stent nearest to the heart). Pressures are measured by ultrasound. These results include the percentage of subjects that maintained primary patency at or below 2.0 without any repeat intervention through the end of the study (three years).
Safety: Composite of Major Procedural (30-day) Adverse Events (AEs)
Time Frame: 30 days
Major procedural events include death, myocardial infarction, acute renal insufficiency, study limb amputation, and access site and treatment site complications requiring surgery or blood transfusion. The results for this outcome measure are the total percent of these events that occurred in each treatment arm within the first 30 days following stent implantations.
Secondary Outcomes
- Primary Assisted Patency(3 years)
- Secondary Patency(3 years)
- Technical Success at Initial Procedure(Time of implant procedure)
- Target Vessel Revascularization (TVR)(3 years)
- Target Lesion Revascularization (TLR)(3 years)
- Improvement in Rutherford Classification (Clinical Success)(3 years)
- Quality of Life Subject Self-assessments (Intermittent Claudication Questionnaire: ICQ) (Clinical Success)(3 years)
- Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Mental Summary Score)) (Clinical Success)(3 years)
- Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Physical Summary Score)) (Clinical Success)(3 years)
- Change in Ankle-Brachial Index (ABI)(3 years)
- Alternate Peak Systolic Velocity Ratio (PSVR) (Equal or Less Than 2.5)(3 years)
- Alternate Peak Systolic Velocity Ratio (Less Than or Equal to 3.0)(3 years)
- Occurrence of Stent Fracture(3 years)