FANTOM II Brief summary FANTOM II is a prospective, multi-center, safety and performance study. The objective is to evaluate the safety of a new scaffold platform in native coronary arteries that includes incorporation of a deformable expansion technology and an enhanced scaffold material that is a polycarbonate co-polymer of tyrosine analogs. This will be accomplished through the implantation and evaluation of the REVA FANTOM Sirolimus-Eluting Bioresorbable Coronary scaffold comprised of Poly(I2DAT -co-lactic acid). 240 patients with clinical evidence of myocardial ischemia or a positive functional study were enrolled (117 patients were enrolled in cohort A and 123 patients in cohort B). Clinical follow-ups are performed as follows: Cohort A: Discharge, 1, 6, 12, 24, 36, 48 & 60 months Cohort B: Discharge, 1, 6, 9, 12, 24, 36, 48 & 60 months Angiographic Follow-up are performed as follows: Cohort A: 6 Months (All Cohort A Patients) Cohort B: 9 Months (All Cohort B Patients) Primary endpoints Major Adverse Cardiac Events (MACE) and Late Lumen Loss at 6 months. CERC Services Study management for 4 French sites : Clinical trial documentation translation, Submission, Set-up activities, Project Management, Monitoring, Safety reporting. Countries 8 countries: Belgium, Brazil, Denmark, France, Germany, Netherlands, Poland and Slovenia. Centers number 28 investigational...
ABILITY Diabetes Global Brief summary ABILITY Diabetes Global is a prospective, multi-center, multinational, randomized, open label (follow-ups blinded), 2-arm parallel groups study. The objective is to compare in diabetic patients eligible for percutaneous coronary intervention (PCI) with minimal exclusion criteria, the efficacy and safety of Abluminus DES+ sirolimus-eluting stents (SES) versus XIENCE Everolimus-Eluting Stents (EES). The objective is to enroll 3000 diabetic patients eligible for PCI at 100 investigational sites and patients will be followed up to two years after procedure. Primary endpoints Ischemia-driven Target Lesion Revascularization (idTLR) at 1-year follow-up (powered for non-inferiority and sequentially superiority). Target lesion failure (TLF – composite of cardiovascular death, target vessel myocardial infarction [MI], or ischemia driven target lesion revascularization) at 1-year follow-up, powered for non-inferiority CERC Services Clinical trial documentation, Submission, Set-up activities (sites selection, insurance management, contract management), Project Management, Monitoring, CoreLab activities, Safety reporting, Clinical report Countries Around 20 countries across Europe, Asia, Australia, Latin America and Japan. Europe: Austria, Belgium, Czech Republic, France, Germany, Ireland, Italy, Poland, Sweden, Switzerland, The Netherlands and United Kingdom. Asia: Bangladesh, India, Malaysia, Singapore, South Korea, Taiwan. Latin America: Brazil and Mexico Center number 100 investigational...
TAVI-1 Brief summary The study title: The TAVI-1 Study: Safety and Performance Study of the Optimum Transcatheter Aortic Valve- First-in-human study to assess feasibility and safety of the Optimum Aortic Valve Implant. The study design: Prospective, non-randomized, single arm, single-center first-in-man, safety and device success study. The recruitment target is 5 patients. The Optimum Transcatheter Aortic Valve (Optimum TAV) System is intended for patients with severe aortic stenosis deemed high-risk or inoperable for Surgical Aortic Valve Replacement (SAVR). The study is in the study start up phase (only submitted to BfArM, who has some questions). Primary endpoints Primary Performance Endpoint: Device Success, defined as – Absence of procedural mortality AND – Correct positioning of a single Optimum TAV into the proper anatomical location AND – Intended performance of the Optimum TAV (no prosthesis-to-patient mismatch, mean aortic valve gradient < 20 mmHg or peak aortic valve velocity < 3 m/sec, AND no moderate or severe prosthetic valve regurgitation). Primary Safety Endpoint All-cause mortality at 30 days. CERC Services Full services (Documents preparation (Protocol, IB, ICF, CRF paper, study plans), regulatory submissions (EC and CA), TMF creation and maintenance, contract negociation with site, study conduct (SIV, SMV, COV), project management, CEC, Core lab, SAE reporting activity, final clinical report, statistics). Countries Germany Center number 1 site in...
EURO SHOCK Brief summary The study title: Testing the value of novel strategy and its cost efficacy in order to improve the poor outcomes in Cardiogenic Shock. The trial design : Prospective, open, multicentre, randomised strategy trial in Cardiogenic Shock. We will test whether initiating, at a very early stage the use of a specific mechanical support device (MSD) namely (peripheral veno-arterial ECMO) to support the circulation at a very early stage, provides sufficient impact on organ perfusion whilst allowing any recoverable heart muscle to recover following revascularisation, and so beneficially alter prognosis. The recruitment target is 428 sites are activated. Primary endpoints All-cause mortality at 30 days CERC Services Monitoring Countries UK, Germany, Belgium, Spain, Norway, Latvia, Italy, Austria Centers number...
KISS Brief summary KISS study is an investigator-initiated, multi-centre, prospective, randomized (1:1), parallel, two-arm, non-inferiority trial aiming to compare two bifurcation percutaneous coronary intervention (PCI) procedures for side branch protection. In the treatment of bifurcation lesion, the role of side branch intervention for improving the safety of Percutaneous Coronary Intervention (PCI), when main branch is treated according to the Murray law with a Proximal Optimization Technique (POT), remains unclear. The KISS study will evaluate the non-inferiority of no side branch intervention versus side branch ballooning, in the setting of single stenting with systematic proximal optimization technique. Primary endpoints Rate of peri-procedural Myocardial Infarction (MI) at discharge or 48h post-procedure whichever comes first as judged by clinical evaluation in association with day-1 troponin evaluation using the ARC-2 definition CERC Services General study management Set-up activities, Clinical trial documentation, Regulatory submissions, eCRF / data-management, Monitoring, CEC activities, CoreLab activities, Statistical analysis, Clinical report Countries France Italy Portugal Spain Switzerland United Kingdom Centers number Up to 20...
CORE LAB TAVI II Brief summary The study is designed to evaluate the safety and effectiveness of the Transcatheter Aortic Valve and Recapturable Delivery System (product of Shanghai MicroPort CardioFlow Medtech Co., Ltd.) It is a prospective, multicenter, single arm, objective performance criteria controlled clinical investigation Primary endpoint Cumulative all cause mortality of 12 months CERC Services Core Lab activities Countries China Number of patients 144 Centers number...
