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GORE VIABAHN® Versus Plain Old Balloon Angioplasty (POBA) for Superficial Femoral Artery (SFA) In-Stent Restenosis

2014-08-27 03:14:26 | BioPortfolio

Summary

This is a prospective, randomized, multi-center study recruiting patients with an in-stent restenosis in the superficial femoral artery. The safety and efficacity of the Viabahn endoprosthesis (W.L. Gore & Associates), a heparin-bonded endoprosthesis, is compared with plain old balloon angioplasty (POBA). In 4 Belgian and 2 German centers a total of 80 Patients will be recruited. Primary endpoint is primary patency at 12 months, defined as no evidence of restenosis or occlusion within the originally treated lesion based on color-flow duplex ultrasound (CFDU) measuring a peak systolic velocity ratio ≤2.5, and without target lesion revascularization (TLR) within 12 months.

In comparison to POBA, it is expected that the use of the Viabahn endoprosthesis (W.L. Gore & Associates) will result in greater 12 month primary patency of treated superficial femoral artery in-stent restenotic lesions.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Conditions

Peripheral Vascular Disease

Intervention

GORE VIABAHN® Endoprosthesis, Plain old balloon angioplasty

Location

Imelda Hospital
Bonheiden
Belgium
2820

Status

Recruiting

Source

Flanders Medical Research Program

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:26-0400

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