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...
EASY TAVI Brief summary The purpose of this study is to determine whether a left ventricular rapid pacing using the valve delivery guide-wire in transcatheter aortic valve implantation (TAVI) reduces the overall procedure duration in comparison with the conventional method (Use of temporary pacing via a right ventricular lead). Primary endpoints Assess the impact of the ventricular pacing strategy on the total duration of a TAVI procedure CERC Services Hospital and Investigators Fees, Project Management, CRF & EDC Management, Monitoring Management, Data Management, CEC, DSMB, SAE Reporting , Statistical, Final Clinical Report Countries France. Centers number 10 centers and 300 patients managed by...
SENIOR Writing session with O. Varenne & C. Dupic Brief summary The main objective of the SENIOR study is to establish the efficacy and safety of the everolimus eluting stent with a biodegradable abluminal polymer (SYNERGY II) associated with a short dual antiplatelet therapy (DAPT) in patients ≥75 years old, suffering from stable angina, silent ischemia (1 month DAPT) or acute coronary syndromes (6 months DAPT) related to significant coronary artery disease and requiring percutaneous coronary intervention. Primary endpoints Composite rate of Major Cardiovascular and Cerebrovascular Events (all-cause death, myocardial infarction, stroke, ischemia-driven target lesion revascularization) at one year CERC Services Full Services including Corelab, CEC & DSMB Management – CERIC Sponsor Countries Belgium, Finland, France, Italy, Latvia, Macedonia, Spain, Switzerland and UK managed by CERC. Center number 43 centers managed by CERC. Lastest News Primary Endpoint results at TCT 2017 by Prof Olivier Varenne and simultaneous publication in Lancet. Presentation of results : Late Breaking Trial at TCT 2017 (Colorado Convention Center, Denver, Colorado)Session : Main Arena III, Title: SENIOR: A Randomized Trial of a Bioresorbable Polymer-Based Metallic DES vs a BMS with Short DAPT in Patients With Coronary Artery Disease Older than 75 Years Date: Wednesday, November 1st, 2017 | 11:00:00 AM – 11:12:00 AM Investigator meeting : Tuesday 31st october Study Protocol SENIOR PROTOCOL_V...
TRUNC Brief summary Prospective, non-randomized, multi-center study assessing the long term safety and efficacy of the self expandable sirolimus eluting Xposition S stent in the treatment of unprotected left main coronary artery disease. Primary endpoints Clinical Endpoint: Target Lesion Failure at 12 months post-procedure Efficacy Endpoint: Angiographic success at 12 months post-procedure: Achievement of <20% final residual stenosis at target lesion (visual estimation) with TIMI 3 flow in main branch. CERC Services Project Management Electronic Data Capture Management Data Management Monitoring CEC activities Core Laboratory Safety Reporting Statistical Activities and Clinical Report Countries France, Germany, Italy, Poland, Switzerland and The Netherlands managed by CERC. Center number 18 centers managed by...
