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

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 2025

Hechelhammer Lukas, Dick Florian, von Allmen Regula, Benecke Ulf, Baumer Andrea, Koeger Philipp, Stillhard Roman

Type

Clinical Studies

Range

Multicentric, KSSG as participating partner

Units

Radiologie und Nuklearmedizin, Gefässchirurgie, Angiologie, Gastroenterology/Hepatology

Status

Ongoing - recruitment active

Start Date

2019

End Date

2025

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.