Phase 4
N=148
GORE VIABAHN ENDOPROSTHESIS Peripheral Vascular Disease Study
Peripheral Vascular Diseases
Bottom Line
View on ClinicalTrials.gov: NCT00228384 ↗Enrolled (actual)
148
Serious AEs
33.1%
Results posted
May 2012
Primary outcome: Primary: Efficacy: Primary Patency at Three Years — 24.2; 25.9 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- GORE VIABAHN Endoprosthesis (Device); Bare Nitinol Stent (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- W.L.Gore & Associates
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy: Primary Patency at Three Years |
24.2; 25.9 | — |
| PRIMARY Safety: Composite of Major Procedural (30-day) Adverse Events (AEs) |
1.4; 0 | — |
| SECONDARY Primary Assisted Patency |
69.8; 88.8 | — |
| SECONDARY Secondary Patency |
79.5; 89.3 | — |
| SECONDARY Technical Success at Initial Procedure |
97.3; 85.7 | — |
| SECONDARY Target Vessel Revascularization (TVR) |
37.5; 35.5 | — |
| SECONDARY Target Lesion Revascularization (TLR) |
34.7; 34.2 | — |
| SECONDARY Improvement in Rutherford Classification (Clinical Success) |
86.7; 91.7 | — |
| SECONDARY Quality of Life Subject Self-assessments (Intermittent Claudication Questionnaire: ICQ) (Clinical Success) |
46.6; 50.1; 20.8; 22.9 | — |
| SECONDARY Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Mental Summary Score)) (Clinical Success) |
50.3; 48.3; 54; 54 | — |
| SECONDARY Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Physical Summary Score)) (Clinical Success) |
33.6; 32.9; 41.9; 38.7 | — |
| SECONDARY Change in Ankle-Brachial Index (ABI) |
0.64; 0.67; 0.95; 0.97 | — |
| SECONDARY Alternate Peak Systolic Velocity Ratio (PSVR) (Equal or Less Than 2.5) |
27.2; 28.6 | — |
| SECONDARY Alternate Peak Systolic Velocity Ratio (Less Than or Equal to 3.0) |
31.3; 29.2 | — |
| SECONDARY Occurrence of Stent Fracture |
2.6; 50.0 | — |
| SECONDARY Occurrence of Stent Fracture |
2.6; 50.0 | — |
| SECONDARY Occurrence of Stent Fracture |
2.6; 50.0 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00228384). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.