radius-HTN Sponsor Name BioHeart Brief summary RADIUS-HTN is a prospective, multi-center, multinational, randomized, 2-arm parallel groups study. The objective is to compare the safety and efficacy of radio frequency renal denervation using the Iberis Renal Denervation System (AngioCare) via radial access compared with femoral access. In parallel a registry is conducted for patients only eligible for radial access. The aim is to include 90 patients in the randomized study. Estimated 20 patients should bee included in the registry. Primary endpoint Change in office systolic blood pressure at 3 months (efficacy endpoint) CERC Services Site selection Regulatory submissions Project management Contract management Monitoring SAE reporting CEC activities Data management Statistical Analysis Countries France, Germany, Switzerland, China Number of investigational sites:...
LVAD Corheart6 Sponsor Name Shenzen Medical Technology Brief summary LVAD Corheart6 is a single arm, prospective, open label and multicenter pre-market study. The objective is to to evaluate the safety and effectiveness of the Corheart 6 VAS when used for the treatment of advanced, refractory heart failure in an European population. The objective is to enroll 50 patients at 10 investigational sites and patients will be followed up to 5 years after procedure. Primary endpoints It is a composite of survival to transplant, recovery or 6 months of support (whichever occurs first), free of disabling stroke (modified Rankin Score > 3) or re-operation to replace the original pump. CERC Services Site selection Regulatory submission Project management Contract management Site monitoring SAE reporting CEC activities DSMB activities Data management Statistical Analysis Countries Around 2 countries across Germany and Austria. Number of investigational sites:...
GLYCAR study Sponsor Name GLYCAR SA. Brief summary GLYCAR STUDY is a Post Market Multicenter clinical investigation of GLYCAR Bovine pericardial patch with EnCap™ Technology in cardiac and vascular repair or reconstruction surgery. The main objective of this study is to collect real-world, long term clinical data in 100 adult and pediatric patients in whom GLYCAR Pericardial patch is used for: pericardial closure, cardiac and great vessel reconstruction and repair, peripheral vascular reconstruction and repair. Primary endpoints Incidence of Glycar Pericardial patch related mortality [Time Frame: 30 days post procedure or hospital discharge (whichever comes first)] Incidence of Glycar Pericardial patch related reintervention [Time Frame: 30 days post procedure or hospital discharge (whichever comes first)] CERC Services CIP review and finalization CRF and ICF Preparation Project management Regulatory submission Sites’ selection and Sites’ contract management Corelab EDC and data management Monitoring activities SAE reporting CEC activities Statistical analysis Final clinical report Study document Countries France, Germany, South Africa, and United States of America (USA) Number of investigational sites: 10 to 12 sites Number of patients:...
evergreen Valiant Captivia physician fEnestRated stent GRaft system in the aortic arch and dEscendiNg thoracic aorta pathologies Sponsor Name Ceric Brief summary EVERGREEN study is a prospective, multi-center, multinational, single arm study. The objective is to evaluate the safety and effectiveness of Valiant Captivia physician fenestrated Stent Graft System in the Aortic Arch and descending aorta pathologies. 30 patients will be enrolled in 9 sites in France (6) and Italy (3). Patients will be followed up to 3 years after procedure. Primary endpoints Safety endpoint: at 30 days post procedure composite of aorta-related mortality, stroke/TIA, paraplegia/paraparesis, left arm/hand ischemia Effectiveness endpoints: stent delivery, vessels unintentional coverage, delivery system removal, aortic lesions exclusion CERC Services Clinical trial documentation, Regulatory Submission, Set-up activities (sites selection, insurance management, contract management), Project Management, Monitoring, CoreLab activities, Safety reporting, Data Management, Clinical report Countries 2 countries in Europe: France and Italy Number of patients: 30 Number of investigational sites:...
care Sponsor Name ROBOCATH Brief summary 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 of the peripheral vasculature. The objective of the study is to assess the feasibility of the R-One TM device in carotid artery stenting. Primary endpoints Procedure technical success, absence of any unplanned manual assistance or conversion to manual CAS for procedural completion CERC Services Study coordination Regulatory submissions Site contract management EDC management Data management Statistical analysis Countries France Number of investigational sites:...
mena tavi Sponsor Name CERIC Grant Giver Name Boston Scientific Brief summary MENA TAVI is a single arm, prospective, open label and multicenter registry. The objective is to evaluate the ACURATE NEO 2 in the Middle East population suffering from severe symptomatic aortic stenosis. The objective is to enroll 100 patients from 6 investigational sites and patients will be followed up to 30 days after procedure. Primary endpoints The primary endpoint is the combined endpoint at discharge of All cause mortality or Any stroke (disabling and non-disabling) CERC Services Regulatory submissions, Project management, Contract management, Monitoring (subcontracted), SAE reporting, Data management/EDC, CEC organization, Corelab activities, Statistical analysis Countries Around 3 countries across Saudi Arabia, Egypt and Lebanon. Number of investigational sites:...
