NCT01601496

Evaluation of FUSION™ Vascular Graft for Above Knee Targets

Study of PERipheral Bypass GraFting: ProspECTive Evaluation of FUSION™ Vascular Graft for Above Knee Targets(PERFECTION)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Maquet Cardiovascular · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the post-market study was to evaluate the safety and performance of the FUSION Vascular Graft.

Detailed description

This study was a prospective, single-arm, multicenter study conducted in Germany and Austria to evaluate the FUSION Vascular Graft in patients with peripheral arterial occlusive disease undergoing above-the-knee bypass. Follow-up visits were performed at 30 days, 6 months, 12 months and included patency and post operative complications not associated with bypass patency.

Conditions

• Peripheral Arterial Occlusive Disease (PAOD)

Interventions

Type	Name	Description
DEVICE	FUSION Vascular Graft	All subjects who received the FUSION Vascular Graft at the baseline implant procedure.

Timeline

• Start date: 2009-10-26
• Primary completion: 2013-07-24
• Completion: 2013-07-24
• First posted: 2012-05-18
• Last updated: 2020-10-14
• Results posted: 2020-10-14

Locations

10 sites across 2 countries: Austria, Germany

Regulatory

• FDA-regulated device study