Back to resultsGORE VIABAHN ENDOPROSTHESIS Peripheral Vascular Disease Study
Primary Purpose
Peripheral Vascular Diseases
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
GORE VIABAHN Endoprosthesis
Bare Nitinol Stent
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Vascular Diseases
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. 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.
Sites / Locations
- Mayo Clinic Phoenix
- Arkansas Heart
- Holy Cross Hospital
- Vascular Surgical Associate
- Midwest Heart Foundation
- Midwest Institute for Minimally Invasive Therapy
- St Francis Medical Center
- St. Johns Hospital/Prairie Education Research
- Ochsner Clinic
- Washington University
- The Cleveland Clinic Foundation
- Midwest Cardiology Research Foundation
- Heritage Valley Health Systems
- Allegheney General Hospital
- St Luke's Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Gore VIABAHN Endoprosthesis
Bare Nitinol Stent (BNS)
Arm Description
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00228384
Brief Title
GORE VIABAHN ENDOPROSTHESIS Peripheral Vascular Disease Study
Official Title
GORE VIABAHN Endoprosthesis Versus Bare Nitinol Stent in the Treatment of Long Lesion (>8cm) Superficial Femoral Artery Occlusive Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
W.L.Gore & Associates
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Vascular Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
148 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gore VIABAHN Endoprosthesis
Arm Type
Active Comparator
Arm Title
Bare Nitinol Stent (BNS)
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
GORE VIABAHN Endoprosthesis
Other Intervention Name(s)
VIABAHN
Intervention Description
Implantation
Intervention Type
Device
Intervention Name(s)
Bare Nitinol Stent
Intervention Description
Implantation
Primary Outcome Measure Information:
Title
Efficacy: Primary Patency at Three Years
Description
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).
Time Frame
3 years
Title
Safety: Composite of Major Procedural (30-day) Adverse Events (AEs)
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Primary Assisted Patency
Description
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.
Time Frame
3 years
Title
Secondary Patency
Description
Secondary patency is defined as maintaining patency in the target vessel after a repeat intervention to correct complete occlusion in the treated arterial segment.
Time Frame
3 years
Title
Technical Success at Initial Procedure
Description
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 Frame
Time of implant procedure
Title
Target Vessel Revascularization (TVR)
Description
This measure shows the percentage of subjects that had at least one repeat intervention performed during their enrollment in the clinical study.
Time Frame
3 years
Title
Target Lesion Revascularization (TLR)
Description
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.
Time Frame
3 years
Title
Improvement in Rutherford Classification (Clinical Success)
Description
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.
Time Frame
3 years
Title
Quality of Life Subject Self-assessments (Intermittent Claudication Questionnaire: ICQ) (Clinical Success)
Description
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.
Time Frame
3 years
Title
Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Mental Summary Score)) (Clinical Success)
Description
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.
Time Frame
3 years
Title
Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Physical Summary Score)) (Clinical Success)
Description
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.
Time Frame
3 years
Title
Change in Ankle-Brachial Index (ABI)
Description
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.
Time Frame
3 years
Title
Alternate Peak Systolic Velocity Ratio (PSVR) (Equal or Less Than 2.5)
Description
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.
Time Frame
3 years
Title
Alternate Peak Systolic Velocity Ratio (Less Than or Equal to 3.0)
Description
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.
Time Frame
3 years
Title
Occurrence of Stent Fracture
Description
The outcome of stent fracture measures the percentages of subjects that had stent fractures, as observed in their 1yr follow-up visit X-rays.
Time Frame
1 year
Title
Occurrence of Stent Fracture
Description
The outcome of stent fracture measures the percentages of subjects that had stent fractures, as observed in their 2yr follow-up visit X-rays.
Time Frame
2 years
Title
Occurrence of Stent Fracture
Description
The outcome of stent fracture measures the percentages of subjects that had stent fractures, as observed in their 3yr follow-up visit X-rays.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Ansel, MD
Organizational Affiliation
Midwest Cardiology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patrick Geraghty, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Mewissen, MD
Organizational Affiliation
St. Luke's Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Arkansas Heart
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Holy Cross Hospital
City
Ft Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Vascular Surgical Associate
City
Austell
State/Province
Georgia
ZIP/Postal Code
30106
Country
United States
Facility Name
Midwest Heart Foundation
City
Lombard
State/Province
Illinois
ZIP/Postal Code
60148
Country
United States
Facility Name
Midwest Institute for Minimally Invasive Therapy
City
Melrose Park
State/Province
Illinois
ZIP/Postal Code
60160
Country
United States
Facility Name
St Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
St. Johns Hospital/Prairie Education Research
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
Ochsner Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Washington University
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Midwest Cardiology Research Foundation
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Heritage Valley Health Systems
City
Beaver
State/Province
Pennsylvania
ZIP/Postal Code
15009
Country
United States
Facility Name
Allegheney General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
St Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23676191
Citation
Geraghty PJ, Mewissen MW, Jaff MR, Ansel GM; VIBRANT Investigators. Three-year results of the VIBRANT trial of VIABAHN endoprosthesis versus bare nitinol stent implantation for complex superficial femoral artery occlusive disease. J Vasc Surg. 2013 Aug;58(2):386-95.e4. doi: 10.1016/j.jvs.2013.01.050. Epub 2013 May 13.
Results Reference
derived
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GORE VIABAHN ENDOPROSTHESIS Peripheral Vascular Disease Study
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