« Terrific job », « perfect collaboration », « Excellent company, fantastic support! » : 87,5% of respondents to our customer satisfaction survey declare they are “very satisfied” with the quality of our work. At CERC, patients come first, and our customers satisfaction is our reward. We want to thank them for their comments and compliments, and let them know that we are doing our best to carry on improving...
“Trial Design Principles for Patients at High Bleeding Risk Undergoing PCI” : The second ARC HBR document has just been published last week ! Co-written by Davide Capodanno, Marie-Claude Morice, Dominick J. Angiolillo, Deepak L. Bhatt, Robert A. Byrne, Roisin Colleran, Thomas Cuisset, Donald Cutlip, Pedro Eerdmans, John Eikelboom, Andrew Farb, C. Michael Gibson, John Gregson, Michael Haude, Stefan K. James, Hyo-Soo Kim, Takeshi Kimura, Akihide Konishi, Martin B. Leon, P.F. Adrian Magee, Yoshiaki Mitsutake, Darren Mylotte, Stuart J. Pocock, Sunil V. Rao, Ernest Spitzer, Norman Stockbridge, Marco Valgimigli, Olivier Varenne, Ute Windhovel, Mitchel W. Krucoff, Philip Urban and Roxana Mehran Abstract: “Investigating the balance of risk for thrombotic and bleeding events after percutaneous coronaryintervention (PCI) is especially relevant for patients at high bleeding risk (HBR). The Academic Research Consortium for HBR recently proposed a consensus definition in an effort to standardize the patient population included in HBR trials. The aim of this consensus-based document, the second initiative fromthe Academic Research Consortium for HBR, is to propose recommendations to guide the design of clinical trials of devices and drugs in HBR patients undergoing PCI. The authors discuss the designs of trials in HBR patients undergoing PCI and various aspects of trial design specific to HBR patients, including target populations, intervention and control groups, primary and secondary outcomes, and timing of endpoint reporting.” Learn...
4 years ago, Prof Tamburino from Catania asked CERC to coordinate the SCOPE II study that he had initiated thanks to a grant from Symetis/Boston Scientific. We gladly agreed to conduct this trial: CERC was created with the express purpose of running trials likely to improve patient outcomes and SCOPE II clearly belongs to that kind of trial. SCOPE II was designed as a randomized trial of the Symetis ACURATE neoTM valve versus Medtronic CoreValve Evolut R and Evolut Pro. 796 patients were enrolled in 23 sites across Europe between April 2017 and April 2019 and were followed-up at 30 days and at 1-year post-procedure. Yesterday was an important day for SCOPE II trial as the last patient visit was completed! The study primary-end point results will be available by end of this year, and we at CERC are proud to run rigorous trials answering critical questions for patients and physicians. Know more about SCOPE II...
We are pleased to announce the arrival of our new trial, the ELECTRODUCER trial. It has just been initiated at sites. Click on the logo below to discover the...
Our CERC Chronicle has just been published. Ability DG, MASTERDAPT, KISS, ARC HBR… Discover CERC’s latest successes and projects! ...
CERC is happy to announce that Concept Medical have entrusted CERC (Massy, France) and Icahn School of Medicine at Mount Sinai (NYC, USA) with the overall management of a large international trial that will assess the efficacy and safety of the ABLUMINUS Sirolimus-eluting DES+ in diabetic patients by comparing it to the Xience EES: ABILITY Diabetes Global. This transatlantic cooperation is a first for CERC, and we are thrilled to be working with Roxana Mehran, Director of Interventional Cardiovascular Research and Clinical Trials at Icahn School of Medicine at Mount Sinai, and her team. The trial addresses a true unmet need of PCI, since diabetic patients continue to suffer high event rates after coronary stenting, even with the best of current second-generation DES. The design of the ABLUMINUS stent has very significant potential to impact the restenosis process in high risk patients, since the sirolimus and biodegradable polymer coating is applied simultaneously to the stent and delivery balloon, thus producing a combined “DES + DEB” in a single device, allowing for the delivery of a very homogeneous drug dose along the entire length and edges of the treated vascular segment. With three world-class PIs (Antonio Colombo, Shigeru Saito and Alexandre Abizaid), the size of the trial (3000 patients) will allow for a non-inferiority analysis for the main endpoints of clinically-driven TLR and TLF, with a sequential superiority analysis for cd-TLR. While it is planned to enroll patients from over 100 sites in Europe, Asia, Latin America and Australia, the trial design has been discussed with the FDA, since the results are intended to be part of a submission package...
