N/A
Completed N=119
GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface in the Treatment of SFA Obstructive Disease (VIPER)
Peripheral Vascular Diseases
Source: ClinicalTrials.gov NCT00541307 ↗
Enrolled (actual)
119
Serious AEs
9.2%
Results posted
Dec 2012
Primary outcomePrimary: Primary Patency at 12 Months — 72.9 percentage of subjects
Summary
The objective of the study is collect data on the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface in the treatment of chronic Superficial Femoral Artery disease. Device patency at 12 months is the primary endpoint.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Patency at 12 Months |
72.9 | — |
| SECONDARY Proportion of Subjects Who Experience Major Device-related Adverse Events Within the First 30 Days |
— | — |
| SECONDARY Primary Assisted Patency |
85.6 | — |
| SECONDARY Secondary Patency |
92.2 | — |
| SECONDARY Device-related Major Adverse Events at 12 Months |
1 | — |
Eligibility Criteria
Inclusion Criteria:>
- lifestyle limiting claudication, rest pain or minor tissue loss>
- ABI (ankle-brachial index) 0.9
- Stenosis (>50%) or occlusion of native SFA (superficial femoral artery) >5cm
- Orifice and 1 cm of SFA are patent
- Popliteal artery is patent at the intercondylar fossa of the femur to the trifurcation
- At least 1 patent run off vessel
- Guidewire and deliver system successfully traversed the lesion
Exclusion Criteria:>
- Untreated flow-limiting aortoiliac occlusive disease
- Any previous stenting or surgery in the target vessel
- Femoral or popliteal aneurysm of target vessel
- No patent tibial arteries
- Prior ipsilateral femoral artery bypass
- Major distal amputation (above the transmetatarsal) in either limb
- Patients with known sensitivity to Heparin
Data sourced from ClinicalTrials.gov (NCT00541307). 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. Informational only — not medical advice.