Clinical trial NCT00228384: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peripheral Vascular Diseases
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2005-09-28
Enrollment: 148
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Efficacy: Primary Patency at Three Years
timeFrame: 3 years
measure: Safety: Composite of Major Procedural (30-day) Adverse Events (AEs)
timeFrame: 30 days
Secondary outcomes:
measure: Primary Assisted Patency
timeFrame: 3 years
measure: Secondary Patency
timeFrame: 3 years
measure: Technical Success at Initial Procedure
timeFrame: Time of implant procedure
measure: Target Vessel Revascularization (TVR)
timeFrame: 3 years
measure: Target Lesion Revascularization (TLR)
timeFrame: 3 years
measure: Improvement in Rutherford Classification (Clinical Success)
timeFrame: 3 years
measure: Quality of Life Subject Self-assessments (Intermittent Claudication Questionnaire: ICQ) (Clinical Success)
timeFrame: 3 years
measure: Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Mental Summary Score)) (Clinical Success)
timeFrame: 3 years
measure: Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Physical Summary Score)) (Clinical Success)
timeFrame: 3 years
measure: Change in Ankle-Brachial Index (ABI)
timeFrame: 3 years
measure: Alternate Peak Systolic Velocity Ratio (PSVR) (Equal or Less Than 2.5)
timeFrame: 3 years
measure: Alternate Peak Systolic Velocity Ratio (Less Than or Equal to 3.0)
timeFrame: 3 years
measure: Occurrence of Stent Fracture
timeFrame: 1 year
measure: Occurrence of Stent Fracture
timeFrame: 2 years
measure: Occurrence of Stent Fracture
timeFrame: 3 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Phoenix
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Heart
state: Arkansas
city: Ft Lauderdale
country: United States
facility: Holy Cross Hospital
state: Florida
city: Austell
country: United States
facility: Vascular Surgical Associate
state: Georgia
city: Lombard
country: United States
facility: Midwest Heart Foundation
state: Illinois
city: Melrose Park
country: United States
facility: Midwest Institute for Minimally Invasive Therapy
state: Illinois
city: Peoria
country: United States
facility: St Francis Medical Center
state: Illinois
city: Springfield
country: United States
facility: St. Johns Hospital/Prairie Education Research
state: Illinois
city: New Orleans
country: United States
facility: Ochsner Clinic
state: Louisiana
city: St Louis
country: United States
facility: Washington University
state: Missouri
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Midwest Cardiology Research Foundation
state: Ohio
city: Beaver
country: United States
facility: Heritage Valley Health Systems
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheney General Hospital
state: Pennsylvania
city: Milwaukee
country: United States
facility: St Luke's Medical Center
state: Wisconsin
Study officials:
affiliation: Midwest Cardiology
name: Gary Ansel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Patrick Geraghty, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Luke's Medical Center
name: Mark Mewissen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.