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...
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...
MAGICAL SV is a prospective, multi-center, multinational, randomized, single-blind, pivotal, 2-arm parallel groups study. The objective is to evaluate the safety and efficacy of the MagicTouchTM Drug coated balloon in treatment of small vessels (≤2.75 mm) in patients with coronary artery disease. A...
eUltra 10k is a post market, prospective, observational, multicenter registry aimed at evaluating the non-inferiority of BioFreedomTM Ultra CoCr Biolimus A9 (BA9)TM coated coronary stent in patient with coronary artery disease treated by Percutaneous Coronary Intervention.
CYCLOPES is a prospective, multicenter, open-label, single arm trial assessing the feasibility and efficacy of an intracoronary ultrasound guided algorithm for calcium modification in patients undergoing percutaneous coronary intervention (PCI) for chronic calcific coronary artery disease. The study...
Tranform II is an investigator-drive prospective, multicentric, international, randomized clinical trial. The objective is to observe and evaluate the efficacy of Magic Touch SCB compared to the gold standard treatment for native vessel disease, namely new-generation everolimus-eluting DES. The...
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...
OPTIXIENCE is an observational, international, multicentre and prospective study that aims to evaluate the clinical outcome of high-risk patients undergoing percutaneous coronary intervention (PCI) with everolimus-eluting stent implantation using intracoronary tools for PCI guidance and optimization...
This is a prospective, multi-center, single-arm, open-label, First in Human clinical trial. Clinical follow-up for all patients will be performed at 30 days, 6 months, 1 year after the procedure, and then until 5 years. The enrollment was finalized in June 2023 with a total of 60 subjects were...
