NCT00617279

GORE PROPATEN Vascular Graft vs. Disadvantaged Autologous Vein Graft

Comparison of Primary Patency Between GORE PROPATEN Vascular Graft and Disadvantaged Autologous Vein Graft For Below-Knee Arterial Bypass (PRODIGY Study)

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: W.L.Gore & Associates · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The primary patency of the GORE PROPATEN Vascular Graft is equivalent to or better than disadvantaged autologous vein graft in an infragenicular peripheral bypass application at 12 months.

Detailed description

Primary patency is defined as hemodynamic evidence of blood flow through an open graft that has maintained uninterrupted patency and has not previously undergone a revision to restore blood flow. A disadvantaged autologous vein is defined as meeting at least one of the two following criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator; (2) Usable ipsilateral or contralateral autologous greater saphenous vein that meets any of the following criteria: (a) Diameter of less than or equal to 3.0 mm; (b) Inadequate length requiring splicing; (c) Poor quality vein that is either sclerotic or phlebitic.

Conditions

• Peripheral Arterial Occlusive Disease

Interventions

Type	Name	Description
DEVICE	GORE PROPATEN Vascular Graft	Arterial Occlusion Bypass
PROCEDURE	Disadvantaged Autologous Vein Graft	Arterial Occlusion Bypass

Timeline

• Start date: 2007-12-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2008-02-18
• Last updated: 2012-01-12
• Results posted: 2012-01-12

Locations

17 sites across 1 country: United States