COLIBRI Brief summary The objective of this study is to evaluate the safety and performance of the Colibri Transcatheter Aortic Heart Valve System for the treatment of symptomatic severe aortic stenosis via transfemoral access in high surgical risk patients. This is a prospective, multicenter, exploratory single arm and controlled clinical investigation compared to recent historical results. Primary endpoint Rate of all-cause mortality and stroke at 30 days post implantation CERC Services Regulatory Submissions Project Management Contract Management Monitoring SAE Reporting Data Management/EDC CEC/DSMB activities Corelab activities Statistical Analysis Countries 3 Countries Number of patients 30 Centers number 7...
bioadaptor Evaluation of a Sirolimus Eluting Bioadaptor as Compared to a Zotarolimus Eluting Stent in De novo Native Coronary Arteries ELX-CL-1805 Brief summary The objective of this study is to verify the safety and efficacy of the investigational device (ELX1805J) for the treatment of ischemic heart disease due to de novo, native coronary artery lesions. Design International, multicenter, randomized, single-blind study (First In Man in Japan, post-market in Germany). 444 Patients will be enrolled at sites in Japan (222) and Germany (222). Primary endpoint Target lesion failure (TLF) assessed at 12 months. CERC Services Data Management/EDC Core Lab activities Safety Management Project Management CEC activities Countries 2 Countries Number of patients 444 Centers number Up to 25...
CRUZ HBR REGISTRY Brief summary Cruz HBR Registry is post-market, prospective, multi-center, open-label, single-arm registry to evaluate the safety and efficacy of the Supraflex Cruz™ sirolimus-eluting coronary stent system in the treatment of all-comer patients with coronary artery disease by Percutaneous Coronary Intervention, to confirm the results from TALENT trial. The secondary objective of this registry is to demonstrate that the Supraflex Cruz™ stent is not inferior to the BioFreedom™ stent in High Bleeding Risk patients. Primary endpoints Composite of cardiovascular death, myocardial infarction not clearly attributable to a non-target vessel and clinically driven target lesion revascularization at 1 year. CERC Services Clinical trial documentation, Submission, Set-up activities, eCRF / data-management, Monitoring, CEC, CoreLab activities, Clinical report Countries France, Germany, Switzerland Centers number 25 investigational...
R– EVOLUTION Brief summary 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. Primary endpoints This study has 2 primary endpoints: Safety Endpoint: For R-ONETM performed PCI, absence of intra-procedural complications, defined as coronary dissection ≥ NHLBI type D, perforation, decrease of TIMI flow (≤2), acute occlusion, visible thrombus formation, significant air embolus during the procedure, traumatic aortic or left main dissection by guiding catheter Efficacy Endpoint: procedure technical success, defined as successful advancement and retraction of all PCI devices (guidewires, balloon catheters and stents) and the successful treatment of all the target lesions using the R-ONETM system and without conversion to manual operation CERC Services Study tart-up activities, Clinical trial documentation, Project management, eCRF, Data management, Monitoring, CEC activities, Safety management, Statistical analysis, Final clinical report Countries France, Belgium, Luxembourg, The Netherlands Center number 6 centers (3 in France, 1 in Belgium, 1 in Luxembourg and 1 in the...
CAOCT Brief summary Intra CoronAry Optical Computerized Tomography in out-of hospital cardiac arrest patients Primary endpoints Rate of misclassification of at least one coronary artery lesion per patient, between angiography and OCT in the detection of unstable coronary artery lesion CERC Services Monitoring, CEC, Corelab Angio, Data Management, Project Management Countries France, Belgium, Serbia Center number Total number 7 (5 in France, 1 in Belgium and 1 in...
VITALE Brief summary A prospective, single arm clinical investigation evaluating safety and effectiveness/performance of the Microport CardioFlow VitaFlowTM II – Transcatheter Aortic Valve System for the treatment of symptomatic severe aortic stenosis via transcatheter access in increased surgical risk patients Primary endpoints Rate of all-cause mortality at 12 months post implantation CERC Services Corelab, Care Review Committee meetings, Data Management, CEC, DSMB, Project Management (without monitoring and site follow up) Countries United Kingdom, Ireland, Denmark, Switzerland, Netherlands (Submissions ongoing), France and Germany Center number 5 centers active, sites to be initiated in Switzerland and...
