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...
BMX Alpha Brief summary 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 will be compared to the results obtained from the BioMatrix FlexTM arm of the LEADERS trial. Primary endpoints Major adverse cardiac events (MACE) in the overall population, defined as composite of cardiac death, myocardial infarction (Q-wave and non-Q-wave), or clinically driven target vessel revascularization (TVR) at 9 months. CERC Services Clinical trial documentation, Submission, Set-up activities, eCRF / data-management, Monitoring, CEC Countries UK, Spain, Switzerland, Thailand. Center number 12...
HYPERION Brief summary A Prospective, multi-center study to evaluate the safety and performance of the Hyperion™ ASD, PDA and VSD Closure Systems. The purpose of this study is to determine the safety, performance and efficacy of the Hyperion™ Occluder Systems during treatment of ASD, PDA and VSD patients. Primary endpoints Success of implantation without death, stroke, any device embolization, puncture site bleeding requiring surgical repair or blood transfusion and without any other device or procedure related MAE at 30 days. Device success defined as ASD, PDA or VSD closure at 6 months post procedure by a Transthoracic echocardiography or a Transesophageal echocardiography. CERC Services Kick off activities, Clinical trial documentation, Regulatory submissions, Project management, eCRF management, Monitoring, CEC activities, SAE reporting activities, Statistical activities. Countries Algeria, France, Germany managed by CERC. China managed by another CRO. Centers number 8 centers managed by...
