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...
It’s a great pleasure to announce that CERC board has welcomed 3 brilliant new members: Drs Thomas Cuisset (France), Darren Mylotte (Ireland) and Peter Smits (The Netherlands). Their arrival will enhance even more CERC’s global reach. Click here to discover all of the CERC...
Investigating the risk balance of thrombotic and bleeding events after percutaneous coronaryintervention (PCI) is especially relevant for patients at high bleeding risk (HBR). In 2019, the Academic Research Consortium for HBR (ARC-HBR) proposed a consensus definition of HBR in an effortto standardize the patient population involved. CERC organized the meetings of the ARC-HBR group. This finally led to the presentation of the consensus document at EuroPCR 2019 and to the simultaneous publication in Circulation and the European Heart Journal. The second initiative from the ARC-HBR is to produce a second consensus document and thus propose recommendations to guide the design of clinical trials of devices and drugs in HBR patients undergoing PCI. Two meetings of the ARC-HBR group took place in Washington, DC, USA, in April 2019, and Paris, France, in October 2019, once again organized by CERC and attended by the same experts from Europe, the USA and Asia, as well as representatives from the US FDA, the Japanese PMDA, a European Notified Body (DEKRA Certification BV, Arnhem, the Netherlands), and observers from the cardiovascular device and pharmaceutical industries. The output of the meetings will be published soon. The authors hope that this second document will promote consistency in trial design across a potential spectrum of applications in HBR patients, including evaluation of novel technologies and iterations of existing devices. This context is particularly important for the ARC-HBR definitions, which are intended for use in patients who have historically been under-represented in device and drug studies, and for whom there is a need for further understanding of both device and drug benefit/risk. ...
