INFINITY-SWEDEHEART Sponsor Name : Elixir Medical Corporation Brief summary The INFINITY-SWEDEHEART trial is a prospective, multicenter, single-blind, randomized registry-based clinical trial. Eligible patients will be randomized 1:1 (DynamX Bioadaptor: Resolute Onyx) The INFINITY-SWEDEHEART study will evaluate the safety and effectiveness of the DynamX Bioadaptor compared to the Resolute Onyx in the treatment of patients with ischemic heart disease with de novo native coronary artery lesions in epicardial vessels. Two thousand four hundred (2400) patients will be recruited over a 12-month period with a 5-year follow-up period. Primary Endpoint(s): Device Oriented Clinical Endpoint (DOCE) of target lesion failure (TLF; cardiovascular death, target vessel myocardial infarction (TV-MI), or ischemia-driven target lesion revascularization (ID-TLR)) at 1 year. Defined as any myocardial infarction not clearly attributed to a non-target vessel. Secondary Endpoint(s): Acute Success endpoints: Device Success (Lesion Level Analysis) Procedural Success (Patient Level Analysis) CERC Services CoreLab activities Countries Approximately 20 participating sites in...
eULTRA 10 K Biosensors Europe S.A. Brief summary eUltra 10k is a post market, prospective, observational, multicenter registry aimed at evaluating the non-inferiority of BioFreedomTM Ultra CoCr Biolimus A9 (BA9)TM coated coronary stent in patient with coronary artery disease treated by Percutaneous Coronary Intervention. Study Hypothesis The hypothesis is that the observed Target Lesion Failure (TLF) rate is noninferior compared to performance goal of 7.8%. Primary endpoints Primary endpoint is Target Lesion Failure (TLF) at 12 months according to ARC-2 definition. CERC Services Set-up activities, Regulatory submission, Monitoring, Clinical event management, eCRF/data management, Data processing, Central data monitoring, Statistical analysis Countries Europe (France, Spain, Portugal, Germany, Austria), Ireland, UK, Switzerland, Maghreb (Tunisia, Algeria) and Macedonia Number of centres: In progress (around 100) Number of planned patients: 10...
DESyne BDS Plus RCT Sponsor Name : Elixir Medical Corporation Brief summary The DESyne BDS Plus Randomised Clinical Trial (RCT) will seek to evaluate the safety, effectiveness and performance of the DESyne BDS Plus DECSS (Test) as compared to the CE Mark approved DESyne X2 Novolimus Eluting Coronary Stent System (DESyne X2 NECSS; DESyne X2) (Control) in the treatment of de novo native coronary artery lesions. 200 Patients will be enrolled at approximately 15 sites in Europe, New Zealand, and Brazil. The primary endpoint is target lesion failure (TLF) at 3 days or through hospital discharge, whichever comes first. Target lesion failure (TLF) is defined as a per-subject composite endpoint of cardiovascular death, target vessel MI, and clinically indicated target lesion revascularization. Imaging Endpoints o QCA: Late lumen loss at 6-month follow-up will be evaluated in the Imaging Subset to test for non-inferiority of DESyne BDS Plus to DESyne X2 Angiographic imaging will be undertaken to assess the vessel, lesion, and stent pre-procedure, during the procedure (peri-procedure), and postprocedure for all patients, and again at 6-month follow-up in the subset of approximately 60 patients (30 in each arm), in the selected imaging centers for the following parameters: Acute recoil MLD % DS OCT: OCT imaging assessment of the lesion and stent will be undertaken both at post-procedure and again at 6-month follow-up in approximately 60 patients (30 in each arm) included in the 6-month angiography subset in the selected imaging centers for the following parameters: Assessment of lumen, and device diameters, areas, and volumes Strut coverage Assessment of thrombus Descriptive analysis lesion and stent morphology CERC Services...
COMPARE STEMI ONE Sponsor Name Research Maatschap Cardiologen Rotterdam Zuid Brief summary This is an investigator initiated multi-center, open-label, randomized (1:1) controlled trial comparing Prasugrel-based short (30-45 days) Dual-Antiplatelet-Therapy (DAPT) followed by Prasugrel monotherapy versus standard 12-month DAPT regimen in 1656 STEMI patients. Study objectives The primary objective of this study is to prove noninferiority regarding safety and effectiveness of short DAPT followed by Prasugrel monotherapy versus standard 12 months of DAPT in patients admitted for STEMI treated by primary PCI. The ancillary objective of the study is to prove that OCT-guided revascularization completion by staged PCI is superior to an angio-guided approach in patients with multivessel disease who have received guideline-based treatment of the culprit lesion. Primary endpoints Incidence of Net Adverse Clinical Events (NACE) at 11 months post DAPT randomization as composite of death, MI, stroke or BARC bleeding 3 or 5. Co- primary endpoint: Post-procedural Minimal Stent Area (MSA) CERC Services CEC Safety reporting Imaging Corelab analyses Statistics Countries The Netherlands, Germany and Italy Number of investigational sites:...
R-One Registry CHANGE Sponsor Name ROBOCATH Brief summary R-One registry (CHANGE) is a single-arm, open-label, multi-center subject registry in Europe and South Africa of the R-oneTM to examine its performance during PCI procedures at hospital discharge, whichever occurs first. Co- primary endpoints Clinical success: Less than 30% residual stenosis (visual estimate) post PCI in the lesion(s) treated with the R-One System, without in-hospital major adverse coronary events (MACE). Technical success: absence of any unplanned manual assistance or conversion to manual PCI for procedural completion CERC Services Study coordination Regulatory submissions Site contract management Data management SAE reporting Statistical analysis Countries France, Belgium, Germany, Poland, South Africa Number of investigational sites:...
OPTI-XIENCE Brief summary An international, multicentre, single-arm and prospective study with a historical control group (XIENCE V USA study) to evaluate the clinical outcome of high-risk patients undergoing percutaneous coronary intervention (PCI) with everolimus-eluting stent implantation using intracoronary tools for PCI guidance and optimization. The hypothesis is that the clinical outcome of patients undergoing PCI with stent implantation can be improved with the use of intracoronary imaging (OCT or IVUS) and/or intracoronary pressure measurements (pressure guidewire) that allow PCI optimization compared with PCI guided by angiography alone. Primary endpoints The 1-year TLF rate, defined as a composite rate of cardiac death, target-vessel MI, and ischemia-driven TLR by either PCI or CABG, within 1 year after PCI. For comparison purposes, the definition of the primary endpoint is identical to that used in the XIENCE V USA study (ARC-1 definition). CERC Services Study management in France Kick off activities, Clinical trial documentation review, Regulatory submissions, Contract management, Project management, Monitoring, Safety reporting, Countries France managed by CERC. Spain and Portugal managed by others CRO. Centers number 17 sites in France managed by CERC....
