GORE VIABAHN ENDOPROSTHESIS Peripheral Vascular Disease Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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GORE VIABAHN Endoprosthesis Versus Bare Nitinol Stent in the Treatment of Long Lesion (>8cm) Superficial Femoral Artery Occlusive Disease

Conditions
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Peripheral Vascular Diseases

Intervention / Treatment
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* Device: GORE VIABAHN Endoprosthesis
* Device: Bare Nitinol Stent


Participation Criteria
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Eligibility Criteria
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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. Angiographic and Lesion Requirements meets protocol criteria. 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. Antegrade and retrograde vascular access on the same common femoral artery at the time of the SFA intervention. Serum creatinine > 2.5 mg/dL within 45 days prior to study procedure. Major distal amputation. Septicemia. Any previously known coagulation disorder. Morbid obesity or operative scarring that precludes percutaneous approach (physician's discretion). Contraindication to anticoagulation or antiplatelet therapy. Known allergies to stent/stent-graft components. History of prior life-threatening reaction to contrast agent. Currently participating in another clinical research trial. Current peritoneal or hemodialysis.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gore VIABAHN Endoprosthesis<br> | Device: GORE VIABAHN Endoprosthesis<br>* Implantation<br>* Other names: VIABAHN;|
| Active Comparator: Bare Nitinol Stent (BNS)<br> | Device: Bare Nitinol Stent<br>* Implantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Primary Patency at Three 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). | 3 years | 
| Safety: Composite of Major Procedural (30-day) Adverse Events (AEs) | 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. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Assisted Patency | Primary assisted patency is defined as when the subject had a repeat intervention to regain patency in order to salvage the stent prior to complete occlusion. | 3 years | 
| Secondary Patency | Secondary patency is defined as maintaining patency in the target vessel after a repeat intervention to correct complete occlusion in the treated arterial segment. | 3 years | 
| Technical Success at Initial Procedure | Technical success is defined as a composite of both a) restoration of superficial femoral artery (SFA) patency with < 30% residual stenosis (narrowing) within the treated arterial segment as viewed on post-procedure completion angiography, and b) Final Hemodynamic Pressure Gradient ≤15mm Hg (mercury). A lower pressure gradient number indicates less resistance to blood flow; i.e., less stenosis or narrowing of the vessel under the pressure of the flow. The results show the percentage of study subjects that had technical success. | Time of implant procedure | 
| Target Vessel Revascularization (TVR) | This measure shows the percentage of subjects that had at least one repeat intervention performed during their enrollment in the clinical study. | 3 years | 
| Target Lesion Revascularization (TLR) | This measure shows the percentage of subjects that had at least one repeat intervention in the target lesion during their enrollment in the clinical study. | 3 years | 
| Improvement in Rutherford Classification (Clinical Success) | The Rutherford Classification is a system used to score Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse): Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene The percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results. | 3 years | 
| Quality of Life Subject Self-assessments (Intermittent Claudication Questionnaire: ICQ) (Clinical Success) | The ICQ is a series of 16 questions asking about leg pain and limitations to activities such as walking specific distances, doing daily activities, worrying about pain, resting during activities, and similar. Most questions specifically ask about only the two weeks prior to answering the completion of the questionnaire. Improvement in Intermittent Claudication Questionnaire (ICQ) is a lower score (0 = best, 100 = worst). A decrease in mean score from baseline indicates an improvement in the patient's condition and an increase indicates a decline. | 3 years | 
| Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Mental Summary Score)) (Clinical Success) | The SF-36 Health Survey (version 2) asks 36 questions to measure health and well-being from the patient's point of view. The subscale and total score ranges from 0 to 100 but is normalized so that a score of 50 is the population mean, with a standard deviation of 10. The SF:36 - Mental Summary Score Questionnaire score must improve in order to be considered for clinical success. An increase in the mean score from baseline indicates an improvement in the patient's condition and a decrease indicates a decline. | 3 years | 
| Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Physical Summary Score)) (Clinical Success) | The SF-36 Health Survey (version 2) asks 36 questions to measure health and well-being from the patient's point of view. The subscale and total score ranges from 0 to 100 but is normalized so that a score of 50 is the population mean, with a standard deviation of 10. The SF:36 - Physical Summary Score Questionnaire score must improve in order to be considered for clinical success. An increase in the mean score from baseline indicates an improvement in the patient's condition and a decrease indicates a decline. | 3 years | 
| Change in Ankle-Brachial Index (ABI) | This test is done by measuring blood pressure at the ankle and the arm while a person is at rest. The ABI is then calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressures in the arm. A normal resting ABI is 0.9 to 1.3. A resting ABI of less than 0.9 is abnormal. An outcome of a higher mean ABI is considered a success. | 3 years | 
| Alternate Peak Systolic Velocity Ratio (PSVR) (Equal or Less Than 2.5) | 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 had a PSVR of equal or less than 2.5. | 3 years | 
| Alternate Peak Systolic Velocity Ratio (Less Than or Equal to 3.0) | 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 had a PSVR of equal or less than 3.0. | 3 years | 
| Occurrence of Stent Fracture | The outcome of stent fracture measures the percentages of subjects that had stent fractures, as observed in their 1yr follow-up visit X-rays. | 1 year | 
| Occurrence of Stent Fracture | The outcome of stent fracture measures the percentages of subjects that had stent fractures, as observed in their 2yr follow-up visit X-rays. | 2 years | 
| Occurrence of Stent Fracture | The outcome of stent fracture measures the percentages of subjects that had stent fractures, as observed in their 3yr follow-up visit X-rays. | 3 years |