- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00228384
GORE VIABAHN ENDOPROSTHESIS Peripheral Vascular Disease Study
GORE VIABAHN Endoprosthesis Versus Bare Nitinol Stent in the Treatment of Long Lesion (>8cm) Superficial Femoral Artery Occlusive Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85054
- Mayo Clinic Phoenix
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Arkansas
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Little Rock, Arkansas, United States, 72211
- Arkansas Heart
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Florida
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Ft Lauderdale, Florida, United States, 33308
- Holy Cross Hospital
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Georgia
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Austell, Georgia, United States, 30106
- Vascular Surgical Associate
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Illinois
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Lombard, Illinois, United States, 60148
- Midwest Heart Foundation
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Melrose Park, Illinois, United States, 60160
- Midwest Institute for Minimally Invasive Therapy
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Peoria, Illinois, United States, 61637
- St Francis Medical Center
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Springfield, Illinois, United States, 62701
- St. Johns Hospital/Prairie Education Research
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Louisiana
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New Orleans, Louisiana, United States, 70121
- Ochsner Clinic
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Missouri
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St Louis, Missouri, United States, 63110
- Washington University
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Ohio
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Cleveland, Ohio, United States, 44195
- The Cleveland Clinic Foundation
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Columbus, Ohio, United States, 43214
- MidWest Cardiology Research Foundation
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Pennsylvania
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Beaver, Pennsylvania, United States, 15009
- Heritage Valley Health Systems
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Pittsburgh, Pennsylvania, United States, 15212
- Allegheney General Hospital
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Wisconsin
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Milwaukee, Wisconsin, United States, 53215
- St Luke's Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Gore VIABAHN Endoprosthesis
|
Implantation
Other Names:
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Active Comparator: Bare Nitinol Stent (BNS)
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Implantation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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). |
3 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.
|
30 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary Assisted Patency
Time Frame: 3 years
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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.
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3 years
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Secondary Patency
Time Frame: 3 years
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Secondary patency is defined as maintaining patency in the target vessel after a repeat intervention to correct complete occlusion in the treated arterial segment.
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3 years
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Technical Success at Initial Procedure
Time Frame: Time of implant procedure
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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)
Time Frame: 3 years
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This measure shows the percentage of subjects that had at least one repeat intervention performed during their enrollment in the clinical study.
|
3 years
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Target Lesion Revascularization (TLR)
Time Frame: 3 years
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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.
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3 years
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Improvement in Rutherford Classification (Clinical Success)
Time Frame: 3 years
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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)
Time Frame: 3 years
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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)
Time Frame: 3 years
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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)
Time Frame: 3 years
|
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)
Time Frame: 3 years
|
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)
Time Frame: 3 years
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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)
Time Frame: 3 years
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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
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Occurrence of Stent Fracture
Time Frame: 1 year
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The outcome of stent fracture measures the percentages of subjects that had stent fractures, as observed in their 1yr follow-up visit X-rays.
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1 year
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Occurrence of Stent Fracture
Time Frame: 2 years
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The outcome of stent fracture measures the percentages of subjects that had stent fractures, as observed in their 2yr follow-up visit X-rays.
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2 years
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Occurrence of Stent Fracture
Time Frame: 3 years
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The outcome of stent fracture measures the percentages of subjects that had stent fractures, as observed in their 3yr follow-up visit X-rays.
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3 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Patrick Geraghty, MD, Washington University School of Medicine
- Principal Investigator: Gary Ansel, MD, Midwest Cardiology
- Principal Investigator: Mark Mewissen, MD, St. Luke's Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SFA 05-03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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