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).
BMX Alpha is a prospective, multi-center, registry designed to enrol 400 patients to 12 international centers. All patients will receive a BioMatrix AlphaTM stent as per clinical practice and will be followed for 2 years for data collection. Major adverse cardiac events (MACE) results at 9 months...
Out-of-hospital cardiac arrest (OHCA) is a leading cause of sudden death in Europe and the United States. Mortality is currently close to 40% among those patients who had been successfully resuscitated after OHCA associated with ventricular fibrillation or pulseless ventricular tachycardia. Coronary...
The ContraBand™ device is intended for treatment of heart failure patients who remain symptomatic despite the use of optimally tolerated guideline directed medical therapy.
The R-OneTM robotic platform is currently indicated for remote delivery and manipulation of coronary guidewires and stent/balloon devices during percutaneous coronary interventions. Robocath is seeking to expand the indication for use to include the common carotid artery, commonly classified as part...
The CELTIC Bifurcation study will examine outcomes for patients treated by planned culotte stenting and compare outcomes with 2 different stent platforms, the next generation Synergy II and the Xience Xpedition DES platforms. ClinicalTrials.gov ID: NCT02232815
R-One registry (CHANGE) is a single-arm, open-label, multi-center subject registry in Europe and South Africa of the R-oneTM to examine its performance during PCI procedures at hospital discharge, whichever occurs first. ID: NCT05853419
This study is a prospective, investigator-initiated, multi-center, single arm, observational registry of performance of Excimer Laser Coronary Atherectomy (ELCA) in standard use cases of percutaneous coronary intervention (PCI). The total study duration is 3 years, including 2 years of recruitment...
This is a prospective, multicenter, exploratory single arm and controlled clinical investigation compared to recent historical results. This pre-CE marked trial is conducted in two countries (France and the UK) with 5 Investigation sites participate to the trial. The recruitment was finalized in...
This is a multicentre, single-blind, prospective randomized investigator-driven trial that will include 2100 patients in 10 countries. Included patients will present a high-risk for restenosis due to clinical profile or coronary lesion complexity and will undergo elective or emergent percutaneous...
