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...
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...
