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

NAActive, not recruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

June 25, 2019

Primary Completion Date

March 31, 2026

Study Completion Date

March 31, 2026

Conditions
Peripheral Arterial Disease
Interventions
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.

Trial Locations (3)

29010

Hospital Carlos Haya, Málaga

CH-9007

Kantonsspital St. Gallen, Sankt Gallen

CH-8401

Kantonsspital Winterthur, Winterthur

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Abbott

INDUSTRY

collaborator

Cantonal Hospital of St. Gallen

OTHER

lead

Kantonsspital Winterthur KSW

OTHER