Project

A prospective randomized, parallel-group, multicentre, superiority trial of the SUPERA peripheral stent system in patients with femoro-popliteal artery disease

Ongoing - recruitment active · 2019 until 2023

Type
Clinical Studies
Range
Multicentric, KSSG as participating partner
Units
Status
Ongoing - recruitment active
Start Date
2019
End Date
2023
Financing
Others
Study Design
Prospective randomized parallel-group, multicentre, superiority trial (1:1) at around four European participating institutions. Enrolment/randomization takes place just before stent placement (wire already through the lesion).
Partner
Kantonsspital Winterthur
Brief description/objective

The primary objective of the study is to investigate, if the Supera® Peripheral Stent System has clinical superiority over EverFlex™ Self-Expanding Peripheral Stent System with Entrust™ Delivery System or as Protégé™ EverFlex™, a standard self-expandable nitinol stent in patients with femoro-popliteal artery disease as measured by the primary patency rate at 24 months.
The key secondary objective of the study is, to compare the proportion of patients with target lesion revascularizations (TLR) or target vessel revascularization (TVR) over 24 months for patients treated with the Supera® Peripheral Stent System compared to patients treated with the control intervention.
The safety objective is to assess and compare the occurrence of access site complications, prolonged hospital stay or need for surgical revision in the different treatment groups.