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

W.L. Gore & Associates

Status: Completed

Conditions: Peripheral Vascular Diseases

Treatments: Device: Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface

Study type: Interventional

Funder types: Industry

Identifiers

NCT00541307

VPR 07-03

Details and patient eligibility

About

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.

Enrollment: 119 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:>

• lifestyle limiting claudication, rest pain or minor tissue loss>
• ABI (ankle-brachial index) < 0.9 or TBI (toe-brachial index) < 0.5 if ABI is >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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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119 participants in 1 patient group

GORE VIABHAN Endoprothesis

Experimental group

Description:

Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface

Treatment:

Device: Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface