BA9™ is a Biosensors proprietary drug. The enhanced lipophilicity should make the BA9™ drug particularly well suited for short-term local delivery from an expanded vascular (coronary) balloon into adjacent vascular tissue. Following successful animal experiments, the conduct of a first clinical...
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 purpose of the SAPIEN 3 study is to assess the safety and device success of the Edwards SAPIEN 3 Transcatheter Heart Valve (S3 THV) and the Edwards Commander and Certitude Delivery Systems in patients with symptomatic, severe aortic stenosis who are indicated for aortic valve replacement. This...
Transcatheter aortic valve implantation (TAVI) is an established treatment option for patients with severe symptomatic aortic stenosis and at increased risk for surgical aortic valve replacement (SAVR). Many novel devices are currently being developed and established transcatheter heart valves...
Current care randomized clinical trial comparing the CE marked Symetis ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System with the CE marked Medtronic CoreValve Evolut R TAVI system (or any future CE-marked CoreValve versions). Transcatheter aortic valve implantation...
