NCT01575808

Multi-center Study for Stent Graft System for Peripheral Artery

The Utility of GP1101 Relative to Surgical Bypass in the Treatment of Femoral / Popliteal Arterial Symptomatic Peripheral Arterial Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: W.L.Gore & Associates · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The utility of GP1101 will be evaluated relative to that of surgical bypass in the treatment of Femoral/Popliteal Arterial Symptomatic Peripheral Arterial Disease. Efficacy will be measured by comparison to a Surgical Bypass Efficacy Goal, and Invasiveness will be measured by comparison to Surgical Bypass data derived from a retrospective study.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	GP1101	Endovascular stent graft implantation

Timeline

• Start date: 2012-04-01
• Primary completion: 2014-08-01
• Completion: 2019-02-01
• First posted: 2012-04-11
• Last updated: 2023-05-12
• Results posted: 2018-02-08

Locations

15 sites across 1 country: Japan