An international, multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) clinical investigation to evaluate the clinical safety and effectiveness of the Coroflex® ISAR NEO stent for the treatment of coronary disease.
RESTORE is a single arm, prospective, multicentre, pilot study to evaluate the safety and performance of AdvaPro Sirolimus Eluting Coronary Stent System in Coronary Artery Stenosis in Indian and European Population. A total of 120 subjects will be recruited across France and India, with...
REVERSE is a prospective, randomised, open-label, international multicentre trial. The objective is to evaluate the safety and efficacy of drug-coated balloon (DCB) treatment compared to drug-eluting stenting (DES) in patients with large coronary artery disease. The objective is to enroll 1436...
The goal of this feasibility study is to evaluate the safety and efficacy of the Renal Stimulation (RNS) by Direct Wire Pacing, during Renal Denervation (RDN) procedure in patient candidate for renal denervation with the ParadiseTM System. The main questions it aims to answer are: Is the RNS before...
SAITO1A is single center, prospective, single arm, First-In-Human study. The objective is to assess the feasibility and safety of the TaviPilot augmented reality guidance software during TAVI procedures, aiming to improve valve positioning precision and, implicitly, reduce implantation depth...
SAITO1B is prospective, single arm, First-In-Human study. The objective is to assess the feasibility and safety of the TaviPilot augmented reality guidance software during TAVI procedures, aiming to improve valve positioning precision and, implicitly, reduce implantation depth variations in patients...
The Aortoseal Endostapling System is intended to provide enhanced fixation between an endovascular graft and the native aorta and to provide enhanced apposition of the endovascular graft to the native aorta. It is indicated in patients undergoing, or having undergone, treatment of an abdominal...
A Prospective Randomized (1:1), Multi-center, International, Open label Clinical trial. The objective is to demonstrate non-inferiority for Target Vessel Failure (TVF) of a treatment strategy with first line SELUTION SLR Drug Eluting Balloon (DEB) plus provisional Drug Eluting Stent (DES) vs...
Prospective, multi-center, non-randomized interventional study to evaluate the safety, effectiveness and performance of the Venus-Vitae Transcatheter Heart Valve System in patients with severe aortic stenosis. 150 subjects will be enrolled in up to 20 sites in multiple countries/regions including...
START YOUNG is a groundbreaking, investigator-initiated, prospective, multicenter, randomized trial comparing surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) using the balloon-expandable Myval THV in patients aged 65 to 75 years with symptomatic severe...
