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