« 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...
Illumina Brief summary The Illumina study has been designed to evaluate the efficacy and safety of the new self-expanding polymer free drug eluting stent – NiTiDES – for SFA manufactured by CID S.p.A. member of Alvimedica group. Currently this device represents the first attempt to embed a controlled and targeted drug elution (2-3 months) with a polymer-free nitinol Platform. Illumina is a prospective and single arm study, which enrolled 100 patients with ischemic obstruction of SFA and proximal popliteal artery. The two co-primary endpoints for the study are primary patency rate at 12 months – efficacy endpoint, and composite event free survival rate at 12 months – safety endpoint. The trial principle investigator is Prof. Dierk Scheinert from Leipzig University hospital. NiTiDES is a polymer free stent eluting the Amphilimus™ formulation (a combination of Sirolimus and Fatty Acid) through the Abluminal Reservoir Technology aiming at obtaining the highest efficacy profile for the patient. The polymer free platform, which is made of Nitinol, is integrally covered by the Bio Inducer Surface coating, a 2nd generation pure carbon ultra thin layer that drastically increases haemo and bio-compatibility. Primary endpoints SAFETY: Composite event–free survival at 12 months: freedom from CEC adjudicated MAE (death, target limb amputation, target limb ischemia requiring surgical intervention or surgical repair of target vessel or clinically-driven target lesion revascularization) and freedom from worsening of the Rutherford score by 2 classes, or to class 5 or 6 EFFICACY: Primary patency at 12 months. Primary patency is defined as absence of clinically-driven target lesion revascularization or binary restenosis. Binary restenosis is defined as a peak systolic velocity ratio (PSVR) >2.4...
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...
