This is a prospective, multicenter, single-arm clinical study. The objective is to enroll up to 60 patients requiring percutaneous coronary intervention (PCI) on up to two de novo coronary artery lesions with reference vessel diameters ≥ 2.25 mm and ≤ 3.5 mm, and lesion lengths of ≤ 34 mm, with...
The purpose of this study is to collect and monitor ongoing safety and performance clinical data of the ACURATE neo2™ aortic bioprosthesis and the ACURATE neo2™ transfemoral delivery system, in the context of an observational investigator-initiated trial (IIT). There are no additional and/or...
R-evolution is a prospective, multicentre single arm clinical study. The purpose of the study is to assess the safety and efficacy of the robotic assistance R-ONETM in elective Percutaneous Coronary intervention. ID: NCT04163393
RADIUS-HTN study is a prospective, multi-center, international, post-market, randomized (1:1) clinical trial in patients with uncontrolled hypertension. The objective is to compare the safety and efficacy of radio frequency renal denervation using the Iberis Renal Denervation System (AngioCare) via...
RE-ADAPT-HF is a prospective, multicenter, randomized, blinded, sham-controlled, feasibility study of renal denervation in patients with chronic heart failure. Randomisation (1:1; Renal Denervation: Sham) of approximately 144 subjects (72 in each arm).
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...
