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...
french biofreedom Brief summary This is a prospective, observational/non-interventional multi-center registry to be conducted at up to 25 French interventional cardiology centers. The purpose of the study is to explore the safety and effectiveness of the BioFreedomTM DCS in standard clinical practice in France and to serve as part of Post Market Surveillance. Primary endpoints Device-oriented composite endpoint (DOCE) at 12 months defined as composite of cardiovascular death (CD), myocardial infarction (MI) not clearly attributable to a non-target vessel and clinically driven target lesion revascularization (cd-TLR). CERC Services All except for statistical analysis: Study start-up activities Clinical trial documentation Project management eCRF Data management Monitoring CEC activities Safety management Final clinical report Countries France Centers number...
PAVE STUDY - KCL Brief summary Title : Paclitaxel assisted balloon Angioplasty of Venous stenosis in haEmodialysis access (PAVE); A double-blind randomised controlled clinical trial to determine the efficacy of paclitaxel-assisted balloon angioplasty of venous stenoses in haemodialysis access Purpose of clinical trial : Randomised Controlled Trial to assess the efficacy of additional paclitaxel-coated balloon fistuloplasty compared to plain balloon fistuloplasty only to preserve the patency of arteriovenous fistulae used for haemodialysis. Number of patients : 211 Primary endpoints The primary endpoint is time to end of target lesion primary patency (TLPP). Secondary endpoints: Angiographically determined late lumen loss The rate of binary angiographic re-stenosis CERC Services Core Laboratory activity : Core laboratory Plan , guidelines for centers (Instructions to the sites, Technical worksheet), Database corelab development, Corelab analysis : QCA and qualitative analysis (Pre , post , 6 months follow-up, event ) Corelab report and statistical Centers number...
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 catheterEfficacy 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...
