NCT03941314

A Superiority Trial of the SUPERA Peripheral Stent System in Patients With Femoro-popliteal Artery Disease

A Prospective Randomized, Parallel-group, Multicentre, Superiority Trial of the SUPERA Peripheral Stent System in Patients With Femoro-popliteal Artery Disease

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Kantonsspital Winterthur KSW · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study (superiority trial) is to compare the Supera® Peripheral Stent System with a standard nitinol self-expanding stent for treatment of femoro-popliteal arterial occlusive disease. Hypothesis: The Supera® stent is superior to a standard nitinol self-expanding stent, for treatment of femoro-popliteal artery disease in terms of (1) primary patency rate and (2) need for revascularization up to 24 months after stent insertion.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	Supera® Peripheral Stent System	The index procedure is placing a selfexpandable stent at a femoro-popliteal location. The way the stenosis or occlusion is traversed is not part of the study. It is mandatory to prepare then the vessel with PTA (at least the size of the stent) and thereafter insert the stent. Post-PTA can be performed with same balloon, but post-PTA is not mandatory to be performed.
DEVICE	EverFlex™ Self-Expanding Peripheral Stent System	The index procedure is placing a selfexpandable stent at a femoro-popliteal location. The way the stenosis or occlusion is traversed is not part of the study. It is mandatory to prepare then the vessel with PTA (at least the size of the stent) and thereafter insert the stent. Post-PTA can be performed with same balloon, but post-PTA is not mandatory to be performed.

Timeline

• Start date: 2019-06-25
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2019-05-07
• Last updated: 2024-03-29

Locations

3 sites across 2 countries: Spain, Switzerland