N/A N=119 Treatment

GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface in the Treatment of SFA Obstructive Disease (VIPER)

Peripheral Vascular Diseases

Bottom Line

View on ClinicalTrials.gov: NCT00541307 ↗

Enrolled (actual)

119

Serious AEs

9.2%

Results posted

Dec 2012

Primary outcome: Primary: Primary Patency at 12 Months — 72.9 percentage of subjects

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: W.L.Gore & Associates
Primary completion: Jun 2011

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	—

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.

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

View full record on ClinicalTrials.gov →

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.