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...
The ContraBand™ device is intended for treatment of heart failure patients who remain symptomatic despite the use of optimally tolerated guideline directed medical therapy.
BIOME wishes to perform a specific study to validate and refine their CT FFR algorithm. The data comprises coronary computed tomography angiography (CCTA) with at least one vessel with invasively measure fractional flow reserve (FFR).
ART-PCTA-02 study is an observational, prospective, post-market, single arm, open label, multicentre study. Within this trial, 60 patients are planned to be enrolled. During the trial, clinical data of the Arthesys PTCA non-compliant catheters family will be collected during angioplasty intervention...
ART-PCTA-01 study is an observational, prospective, post-market, single arm, open label, multicentre study. Within this trial, 60 patients are planned to be enrolled. During the trial, clinical data of the Arthesys PTCA catheters family will be collected during angioplasty intervention of coronary...
