NCT01108861

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

The GORE VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Versus Plain Old Balloon Angioplasty (POBA) for the Treatment of Superficial Femoral Artery (SFA) In-Stent Restenosis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Flanders Medical Research Program · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral Vascular Disease

Interventions

Type	Name	Description
DEVICE	GORE VIABAHN® Endoprosthesis	GORE VIABAHN® Endoprosthesis
DEVICE	Plain old balloon angioplasty	Plain old balloon angioplasty

Timeline

• Start date: 2010-05-01
• Primary completion: 2013-03-01
• Completion: 2014-03-01
• First posted: 2010-04-22
• Last updated: 2014-09-03

Locations

6 sites across 2 countries: Belgium, Germany