GORE VIABAHN ENDOPROSTHESIS Peripheral Vascular Disease Study

NCT ID: NCT00228384

Last Updated: 2012-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2011-01-31

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.

Conditions

Peripheral Vascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gore VIABAHN Endoprosthesis

Group Type: ACTIVE_COMPARATOR

GORE VIABAHN Endoprosthesis

Intervention Type: DEVICE

Implantation

Bare Nitinol Stent (BNS)

Group Type: ACTIVE_COMPARATOR

Bare Nitinol Stent

Intervention Type: DEVICE

Implantation

Interventions

GORE VIABAHN Endoprosthesis

Implantation

Intervention Type: DEVICE

Bare Nitinol Stent

Implantation

Intervention Type: DEVICE

Other Intervention Names

VIABAHN

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

W.L.Gore & Associates

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gary Ansel, MD

Role: PRINCIPAL_INVESTIGATOR

Midwest Cardiology

Patrick Geraghty, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Mark Mewissen, MD

Role: PRINCIPAL_INVESTIGATOR

St. Luke's Medical Center

Locations

Mayo Clinic Phoenix

Phoenix, Arizona, United States

Arkansas Heart

Little Rock, Arkansas, United States

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Vascular Surgical Associate

Austell, Georgia, United States

Midwest Heart Foundation

Lombard, Illinois, United States

Midwest Institute for Minimally Invasive Therapy

Melrose Park, Illinois, United States

St Francis Medical Center

Peoria, Illinois, United States

St. Johns Hospital/Prairie Education Research

Springfield, Illinois, United States

Ochsner Clinic

New Orleans, Louisiana, United States

Washington University

St Louis, Missouri, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Midwest Cardiology Research Foundation

Columbus, Ohio, United States

Heritage Valley Health Systems

Beaver, Pennsylvania, United States

Allegheney General Hospital

Pittsburgh, Pennsylvania, United States

St Luke's Medical Center

Milwaukee, Wisconsin, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 23676191 (View on PubMed)

Other Identifiers

SFA 05-03

Identifier Type: -

Identifier Source: org_study_id