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GORE VIABAHN ENDOPROSTHESIS Peripheral Vascular Disease Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00228384
Recruitment Status : Completed
First Posted : September 28, 2005
Results First Posted : May 28, 2012
Last Update Posted : June 4, 2012
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates

Tracking Information
First Submitted Date  ICMJE September 26, 2005
First Posted Date  ICMJE September 28, 2005
Results First Submitted Date  ICMJE January 27, 2012
Results First Posted Date  ICMJE May 28, 2012
Last Update Posted Date June 4, 2012
Study Start Date  ICMJE September 2005
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2012)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 26, 2005)
  • Efficacy: Primary patency at three years post-procedure
  • Safety: Composite of major procedural (30-day) adverse events
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2012)
  • Primary Assisted Patency [ Time Frame: 3 years ]
    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 [ Time Frame: 3 years ]
    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 [ Time Frame: Time of implant 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) [ Time Frame: 3 years ]
    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) [ Time Frame: 3 years ]
    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) [ Time Frame: 3 years ]
    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) [ Time Frame: 3 years ]
    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) [ 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 - 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) [ 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.
  • 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.
  • Alternate Peak Systolic Velocity Ratio (PSVR) (Equal or Less Than 2.5) [ Time Frame: 3 years ]
    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) [ Time Frame: 3 years ]
    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 [ Time Frame: 1 year ]
    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 [ Time Frame: 2 years ]
    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 [ Time Frame: 3 years ]
    The outcome of stent fracture measures the percentages of subjects that had stent fractures, as observed in their 3yr follow-up visit X-rays.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2005)
  • • Primary assisted patency
  • • Secondary patency
  • • Technical success
  • • Target vessel revascularization
  • • Target lesion revascularization
  • • Clinical Success
  • • Primary composite safety and efficacy endpoint
  • • Quality of Life subject self-assessments
  • • Change in ankle-brachial index (ABI)
  • • Alternate Peak Systolic Velocity Ratios
  • • Quantitative angiographic assessment of patterns of restenosis
  • • Occurrence of stent fracture
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE GORE VIABAHN ENDOPROSTHESIS Peripheral Vascular Disease Study
Official Title  ICMJE GORE VIABAHN Endoprosthesis Versus Bare Nitinol Stent in the Treatment of Long Lesion (>8cm) Superficial Femoral Artery Occlusive Disease
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Vascular Diseases
Intervention  ICMJE
  • Device: GORE VIABAHN Endoprosthesis
    Implantation
    Other Name: VIABAHN
  • Device: Bare Nitinol Stent
    Implantation
Study Arms  ICMJE
  • Active Comparator: Gore VIABAHN Endoprosthesis
    Intervention: Device: GORE VIABAHN Endoprosthesis
  • Active Comparator: Bare Nitinol Stent (BNS)
    Intervention: Device: Bare Nitinol Stent
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 9, 2011)
148
Original Enrollment  ICMJE
 (submitted: September 26, 2005)
150
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00228384
Other Study ID Numbers  ICMJE SFA 05-03
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party W.L.Gore & Associates
Study Sponsor  ICMJE W.L.Gore & Associates
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gary Ansel, MD Midwest Cardiology
Principal Investigator: Patrick Geraghty, MD Washington University School of Medicine
Principal Investigator: Mark Mewissen, MD St. Luke's Medical Center
PRS Account W.L.Gore & Associates
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP