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GORE VIABAHN ENDOPROSTHESIS Peripheral Vascular Disease Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT00228384
First received: September 26, 2005
Last updated: May 25, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Peripheral Vascular Diseases
Device: GORE VIABAHN Endoprosthesis
Device: Bare Nitinol Stent
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: GORE VIABAHN Endoprosthesis Versus Bare Nitinol Stent in the Treatment of Long Lesion (>8cm) Superficial Femoral Artery Occlusive Disease

Resource links provided by NLM:


Further study details as provided by W.L.Gore & Associates:

Primary Outcome Measures:
  • Efficacy: Primary Patency at Three Years [ Time Frame: 3 years ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The outcome of stent fracture measures the percentages of subjects that had stent fractures, as observed in their 3yr follow-up visit X-rays.


Enrollment: 148
Study Start Date: September 2005
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Gore VIABAHN Endoprosthesis Device: GORE VIABAHN Endoprosthesis
Implantation
Other Name: VIABAHN
Active Comparator: Bare Nitinol Stent (BNS) Device: Bare Nitinol Stent
Implantation

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00228384

Locations
United States, Arizona
Mayo Clinic Phoenix
Phoenix, Arizona, United States, 85054
United States, Arkansas
Arkansas Heart
Little Rock, Arkansas, United States, 72211
United States, Florida
Holy Cross Hospital
Ft Lauderdale, Florida, United States, 33308
United States, Georgia
Vascular Surgical Associate
Austell, Georgia, United States, 30106
United States, Illinois
Midwest Heart Foundation
Lombard, Illinois, United States, 60148
Midwest Institute for Minimally Invasive Therapy
Melrose Park, Illinois, United States, 60160
St Francis Medical Center
Peoria, Illinois, United States, 61637
St. Johns Hospital/Prairie Education Research
Springfield, Illinois, United States, 62701
United States, Louisiana
Ochsner Clinic
New Orleans, Louisiana, United States, 70121
United States, Missouri
Washington University
St Louis, Missouri, United States, 63110
United States, Ohio
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Midwest Cardiology Research Foundation
Columbus, Ohio, United States, 43214
United States, Pennsylvania
Heritage Valley Health Systems
Beaver, Pennsylvania, United States, 15009
Allegheney General Hospital
Pittsburgh, Pennsylvania, United States, 15212
United States, Wisconsin
St Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
W.L.Gore & Associates
Investigators
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
  More Information

No publications provided by W.L.Gore & Associates

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT00228384     History of Changes
Other Study ID Numbers: SFA 05-03
Study First Received: September 26, 2005
Results First Received: January 27, 2012
Last Updated: May 25, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014