STRENGTH Brief summary The Strength study aim to evaluate the use of the RenalGuard device to protect the patients at high risk to develop acute kidney injury following a complex cardiovascular intervention requiring a high volume of contrast. Primary endpoints Occurence of contrast-induced nephropathy [ Time Frame: Within 5 days ] The occurence of contrast-induced nephropathy will be determined: by an elevation, within 3 days from requiring contrast-procedure, of the serum creatinine (rise of 0.3mg/dl or of 25% compared to basal value) and/or by the need for dialysis within 5 fays from requiring contrast-procedure CERC Services Full package: submission, monitoring, CEC, statistics, final report. Countries France & Germany managed by CERC. Centers number 11 centers managed by...
CONSISTENT CTO Brief summary The purpose of this study is to demonstrate that enhanced vascular healing with the Synergy stent should minimize the risk of late aneurysm formation and potential clinical complications but not at the cost of enhanced efficacy. Primary endpoints The primary stent endpoint is 12-month target vessel failure (TVF) rate [ Time Frame: 12 months ] The primary stent endpoint is 12-month target vessel failure (TVF) rate, defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or cardiac death. The primary balloon endpoint is device procedural success [ Time Frame: 1 month ] Successful delivery of the Emerge Coronary Dilatation catherter across the lesion and Successful inflation and removal of the Emerge Coronary Dilatation catherter with absences of clinically significant vessel perforation or flow limiting vessel dissection, reduction in thrombolysis in myocardial infarction (TIMI) flow from baseline, clinically significant arrythmias requiring medical treatment or device intervention following dilatation with Emerge balloon and Achievment of final TIMLI 3 flow for the target lesion at the conclusion of the index procedure. The primary balloon endpoint will be evaluated in patients where an attempt to use an Emerge Coronary Dilatation catherter is made. CERC Services Full services – CERIC Sponsor: Submission, Monitoring, Statistics, Final report, CEC. Countries UK managed by CERC. Centers number 6 centers managed by...
CELTIC Brief summary This study will examine outcomes for patients treated by planned culotte stenting and compare outcomes with 2 different stent platforms, the next generation Synergy II and the Xience Xpedition DES platforms. Primary endpoints Composite measure of Adverse events [ Time Frame: 9 months ] Composite of: Death, Myocardial Infarction, CVA, Target Vessel Failure (Composite of Target Vessel Revascularization and Target Vessel Inadequacy), Definite or Probable stent thrombosis (ARC criteria [14]), Binary angiographic restenosis CERC Services Full services – CERIC Sponsor: Submission, Monitoring, Statistics, Final report, CEC. Countries UK & Ireland managed by CERC. Centers number 9 centers managed by...
ACTIVATION Investigator Meeting 2017 Brief summary: Randomized study comparing the outcome of TAVI in patient suffering from coronary artery disease. The patients are randomized in either PCI before the TAVI or no PCI before the TAVI. Primary endpoints: A composite of mortality and rehospitalisation at 12 months. CERC Services: Submission, Monitoring, CEC. Countries: UK, France & Germany managed by CERC. Center number: 17 centers managed by...
MAVERIC Brief summary The objective of the study is to evaluate the safety and performance of the ARTO System in patients with mitral valve regurgitation (MR) associated with congestive heart failure (CHF). Primary endpoints Major Adverse Event Rate to 30 days post-procedure (death, myocardial infarction, cardiac tamponade, device related cardiac surgery, stroke, renal failure) Mitral Regurgitation grade and change from baseline to 30 days Device Technical Success (At exit from cath lab, alive, with Successful access, delivery and retrieval of the device delivery system, and Deployment and correct positioning (including repositioning/recapture if needed) of the single intended device, and No need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure) CERC Services Regulatory Submissions Project Management Monitoring Data Management CEC activities DSMB activities SAE reporting Core Laboratory Countries Australia, France, Italy, Latvia, South Africa and UK managed by CERC. Center number 13 centers managed by CERC....
