« Medical imaging has advanced considerably over the last 40 years since the first angioplasty was performed and now plays an important role in the evaluation of existing and novel therapies. The Corelab at CERC provides expert, centralized and independent analysis of patient imaging data. This data informs the medical community and is used for CE mark approvals and FDA submissions. We work with medical experts across a range of specialties to provide Corelab services for angiographic, CT, Echo, OCT, IVUS and ECG images. Over the years we have analysed imaging data of thousands of patients in multiple clinical trials and registries and our data has been presented at hundreds of international meetings. No, we don’t spend all our time locked in dark rooms looking at screens! We work with our sponsors to determine the type of imaging data and analysis that will best answer their research question. We work with our project managers to develop a corelab package outlining to the clinical investigation sites the process for acquiring and transferring the imaging data and we work with our data managers to develop the CRF so that we have all the data required to answer the research question posed by the sponsor. » Antoinette Neylon, Corelab Manager @CERC ...
TARGET FIRST Brief summary TARGET FIRST is a prospective, international, multicentre, open-label, randomized (1:1) post-market study to evaluate the impact of Firehawk stent, a drug eluting stent (DES) with high biocompatibility feature, associated with a complete revascularization when needed and short post-procedural Dual Antiplatelet Therapy (DAPT) (consisting of a reduced duration of DAPT followed by P2Y12 inhibitor monotherapy up to 12 months), in reaching non-inferior Net Adverse Clinical and Cerebral Events (NACCE) among clinically stable, low to moderate complexity acute Myocardial Infarction (MI) patients. The secondary objective is to evaluate the impact of Firehawk stent, associated with a complete revascularization when needed and a short post-procedural DAPT, in reducing bleeding events among clinically stable, low to moderate complexity acute MI patients. Primary endpoints Net Adverse Clinical and Cerebral Events (NACCE) defined as a composite of all cause death, non-fatal myocardial infarction, definite/probable stent thrombosis, stroke, or Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at 11 months post randomization (12 months post index procedure). CERC Services Site qualification Regulatory Submissions (except in France) Project Management Data Management Contracts Management (except in France) Monitoring SAE Reporting CEC Countries 8 (Austria, Belgium, France, Italy, The Netherlands, Portugal, Spain, Switzerland) Centers number Approximately 50...
Enjoy the replay of #aictPCR session about Complications, with our CERC and CERC Asia experts! 👉 https://bit.ly/2WvInvG...
The ABILITY Diabetes Global study comparing the ABLUMINUS Sirolimus eluting stent from Concept Medical to the XIENCE Everolimus Eluting stent from Abbott Vascular in diabetic patients is conducted in transatlantic cooperation between CERC and Icahn School of Medicine at Mount Sinai (NY, USA). Patient inclusion has recently begun, reaching enrollment of the first 100 patients out of a total of 3000 patients in early November. Read more about this trial...
Compare HBR 60 80 Brief summary An Investigator-initiated, multi-center, randomized controlled trial to compare the outcome of the ultrathin stent strut Supraflex Cruz stent to the thin stent strut Ultimaster Tansei stent in a PCI population at high bleeding risk. Primary endpoints Net Adverse Clinical Endpoints (NACE) defined as a composite of cardiovascular death, MI, TVR, stroke and major bleeding events (BARC 3 or 5) at 12 months. CERC Services Kick-off activities Clinical trials documentation Project management Clinical Events Committee (CEC) activities Corelab activities Data monitoring Committee (DMC) activities Statistical activities Administrative tasks Countries The Netherlands Centers number 10 centers managed by...
