COMPARE ABSORB Brief summary This is a multicentre, single-blind, prospective randomized investigator-driven trial that will include 2100 patients in 10 countries. Included patients will present a high-risk for restenosis due to clinical profile or coronary lesion complexity and will undergo elective or emergent percutaneous coronary intervention. Once included in the study, patient will receive either Absorb scaffold or Xience stent and will be followed for 5 years. The results of this study will help to assess the noninferiority of the everolimuseluting bioresorbable scaffold (BRS) to the everolimus eluting cobalt chromium metallic stent (EES) in target lesion failure(TLF) at 1 year and the superiority of the BRS to the EES in TLF between 1 and 5 years. Primary endpoints Target lesion failure (TLF) as defined as a composite of Cardiac death Myocardial infarction (MI) in target vessel territory (SCAI consensus for periprocedural MI, 3rd universal definition for spontaneous or other MI) Clinically Indicated Target lesion revascularization CERC Services Regulatory Submissions Project management Contract Managment Monitoring Data Management AE Reporting Organization of DSMB Countries Belgium Czech Republic France Germany Italy Netherlands Poland Spain Switzerland United Kingdom Center number 49 centers managed by CERC....
MASTER DAPT aManagement of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen Brief summary The study compares two lengths of medication therapy (a shortened versus a prolonged dual antiplatelet therapy) in order to prevent thrombus (blood cloth) formation after the successfully treatment for coronary heart disease with a drug covered stent (metallic tube). This comparison will be done in patients who, compared to the average patient, are more likely to suffer from complications on antiplatelet therapy (bleeding). Both durations are within the current medical recommendations. The aim of this study is to help improve further standard antiplatelet duration guidelines. The study design is an investigator-initiated, randomized, multi-center, clinical trial to be conducted in 111 interventional cardiology centers managed by CERC in across the globe excluding USA and in total in 140 centers worldwide. The study includes 2 x 2150 patients (i.e. 4300 patients) Randomization will occur at one month after the PCI procedure. The expected duration of participation for each patient is 14 months. Primary endpoints This study has 3 primary endpoints: 1) Net adverse clinical endpoints (NACE) defined as a composite of all-cause death, myocardial infarction, stroke and bleeding events defined as BARC 3 or 5 2) Major adverse cardiac and cerebral events (MACCE) defined as a composite of all-cause death, myocardial infarction and stroke 3) Major or clinically relevant non-major bleeding (MCB) defined as a composite of type 2, 3 and 5 BARC bleeding...
SCOPE II Brief summary SCOPE-II is a sponsor-initiated, current care randomized, controlled, non-inferiority trial evaluating safety and clinical efficacy of the Symetis ACURATE neo compared to the Medtronic Evolut R bioprosthesis in transfemoral transcatheter aortic valve implantation. Primary endpoints Composite of all-cause mortality or stroke at 1 year. CERC Services Clinical trial documentation, Submission, Set-up activities, eCRF / data-management, Monitoring, CEC, DSMB, CoreLab activities, Clinical report Countries UK, Germany, France, Denmark, Spain and Italy. Center number...
eBiomatrix Brief summary A French post-market Observational/Non-interventional Study of the BioMatrix Flex™ and BioMatrix NeoFlex™drug eluting stents with 6-month DAPT. The purpose of this observational study is to capture, in French Centers, clinical data of the BioMatrix Flex™ and BioMatrix NeoFlex™ Drug Eluting Coronary Stents System (Biolimus A9, BA9™-) in normal practice, in patients treated with 6-month DAPT, and to compare the outcomes to those of previous e-biomatrix registries with longer DAPT durations. Primary endpoints Major adverse cardiac and cerebrovascular events (MACCE) in the overall population, defined as composite of all-cause death, cerebrovascular accidents, non-fatal myocardial infarction or clinically-driven target vessel revascularization at 6 months. CERC Services Study start-up activities, Clinical trial documentation, Project management, eCRF, Data management, Monitoring, CEC activities, Safety management, DSMB management, Statistical activities, Final clinical report. Countries France Centers number 32 centers managed by...
EURO-CTO Presentation during the EuroPCR 2017 by Gerald Werner 2Presentation during the EuroPCR 2017 by Gerald Werner Brief summary CTOs are common among patients with angina, and are detected in around 20% of patients undergoing coronary angiography. Treatment of CTO has been found to constitute only 7% of PCI practice on average. One of the reasons for the under-presentation of CTOs in PCI target lesions is the lack of evidence-based medical data on treatment indications, and the continued low level of accepted evidence for the treatment of CTOs by PCI in PCI guidelines. Patients with a CTO represent patients with stable coronary artery disease. The COURAGE trial comparing PCI with optimal medical therapy in stable coronary disease did not show a difference in mortality or myocardial infarction between the two treatment options. However, CTOs were not included in the COURAGE trial. But that trial did confirm the superiority of PCI over OMT in controlling symptoms of angina, with a high cross-over rate to PCI. Whether PCI for CTO is superior to OMT in reducing MACE in those patients with a large ischaemic burden has never been tested in a randomized controlled trial. While there is compelling evidence from registry studies of a clinical and prognostic benefit following successful PCI of CTO compared with PCI failure, there has been no randomized controlled trial of contemporary PCI using drug-eluting stents versus optimal medical therapy. The COURAGE trial nuclear sub-study confirms both that prognosis is closely related to the extent of residual ischaemia and that PCI is more effective in reducing residual ischaemia than optimal medical therapy alone. This confirms earlier retrospective data...
