EBC Main Investigator Meeting 2017 Brief summary Treatment of bifurcation coronary lesions remains a difficult area, in which best practice is yet to be established. This is particularly true with respect to unprotected left main stem stenting. Whereas for non-left main bifurcation lesions there is a consensus that a single stent strategy is to be preferred where appropriate, for the left main, both the “main vessel” and the “side vessel” are main epicardial coronary arteries, and therefore of paramount importance in their own right. Non-randomised data suggest that even in this bifurcation setting, a single stent strategy may be preferred, but these data are naturally confounded by selection bias. We therefore plan to undertake a randomised study of left main stem true bifurcation lesions (type 1,1,1 or 0,1,1). Patients will be treated either with a planned single stent strategy or a planned dual stent strategy according to randomisation. Primary endpoints (Composite of ) Death, Myocardial infarction and Target Lesion Revascularisation at 12 months CERC Services Full Services – CERIC Sponsor : General study management, Regulatory submissions, Monitoring, CEC and DSMB management and Angiographic core laboratory. Countries Denmark, France, Germany, Italy, Spain, Serbia, Latvia, UK, Ireland, Poland and Russia Centers number 32 active sites managed by...
LEADERS FREE 2 Brief summary To demonstrate that the BioFreedomTM Drug Coated Stent is non-inferior to the Gazelle™ BMS arm of the Leaders Free study in high bleeding risk patients treated with one month DAPT only Primary endpoints Safety: The composite of cardiac death and myocardial infarction at 1 year Efficacy: The incidence of clinically driven target lesion revascularization at 1 year CERC Services CEC Monitoring Core Laboratory Regulatory Countries 85 sites in total distributed throughout Europe and North America (US and Canada). CERC is responsible for the European sites. These are distributed by 5 countries: France, Denmark, Germany, UK and Italy. Centers number 16 centers managed by CERC. Latest News EuroPCR 2017: Two-year follow-up of LEADERS FREE ACS: is there a place left for BMS in ACS?...
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...
VIVA Presentation during the EuroPCR 2017 by Ran Kornowski Brief summary Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis. A Prospective, Observational Post-market Study. This observational study is intended to collect real-world (post-approval use) data regarding the clinical utility and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI). Primary endpoints Primary safety endpoint: Cardiovascular death at 30 days post-index procedure. Primary efficacy endpoint: Lack of significant aortic stenosis (defined as mean gradient > 40 mmHg) or insufficiency (defined as > moderate severity) at one year follow-up using clinical evaluation and echocardiography. CERC Services Kick off activities, Clinical trial documentation, Regulatory submissions, Project management, eCRF management, Monitoring, CEC activities, Core Laboratory SAE reporting activities, Statistical activities, Final clinical report. Countries France, Germany, Israel, Italy. Center number 23 centers managed by CERC. About VIVA – Editorial published in JACC Cardiovascular interventions Article published in JACC Cardiovascular...
Leaders Free A world premiere trial focusing on the « HBR » Dr Philip Urban LEADERS-FREE is a randomized double-blinded trial which was designed to assess the combination of a short course (1 month) of DAPT with either the BioFreedom DCS (drug-coated stent) or the Gazelle BMS in patients with at least one of several criteria for an increased bleeding risk: advanced age, oral anticoagulant treatment, recent bleeding, anaemia, and co-morbid conditions such as chronic renal failure or cancer. The trial has three central features: 1. A focus on a “forgotten” patient subset 2. A double-blinded design (neither the patient nor the operator will know whether a BioFreedom DCS or a BMS control is implanted) 3. The use of two separate co-primary endpoints at 1 year: (BioFreedom vs. BMS) non-inferiority for safety (death, MI and urgent TLR) and superiority for efficacy (any clinically driven TLR) The recruitment was finalized in May 2014 with the inclusion of 2466 patients in 68 European, Asian, Australian and Canadian sites. The primary study endpoints, which were reached in May 2015, will be presented by Philip Urban in the Late Breaking Trials session at TCT 2015 in San Francisco. CERC is in charge of the study management, monitoring and the Angiographic Corelab as well as organization of the CEC and DSMB....
