ACURATE IDE Brief summary The objective of ACURATE IDE is to evaluate safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR. Primary endpoints Safety : Composite of all-cause mortality, all stroke, life-threatening and major bleeding, stage 2 and 3 acute kidney injury and major vascular complications at 30 days. Effectiveness : Composite of all-cause mortality and disabling stroke at 1 year. CERC Services CEC Countries Canada, USA Centers number 50 investigational...
SCOPE I Brief summary The objective of SCOPE I is to compare the performance of the ACURATE neo/TF to the SAPIEN 3 transcatheter aortic bioprosthesis with regard to early safety and clinical efficacy at 30 days. The Secondary objectives is to compare the ACURATE neo/TF with the SAPIEN 3 aortic bioprosthesis with regard to secondary clinical and echocardiographic endpoints at 30 days, 1 year and 3 years Primary endpoints Modified* combined 30-day early safety and clinical efficacy endpoint as defined by VARC-2: – All-cause mortality – All stroke (disabling and non-disabling) – Life-threatening or disabling bleeding – Acute kidney injury (stage 2 or 3, including renal replacementtherapy) – Coronary artery obstruction requiring intervention – Major vascular complicationValve-related dysfunction requiringrepeat procedure (balloonaortic valvuloplasty, TAVI or SAVR in a separate intervention) – Rehospitalization for valve-related symptoms or worsening congestive heart failure – Valve-related dysfunction: – Prosthetic aortic valve stenosis: mean aortic valve gradient ≥20 mmHg, effective orifice area (EOA) ≤ 1.1cm2 (if body surface area (BSA) ≥ 1.6cm2) or ≤ 0.9 cm2 (if BSA < 1.6cm2)and/or Doppler velocity index (DVI) < 0.35 (for LVOT>2.5cm: < 0.20) according to VARC-2 AND/OR – Moderate or severe prosthetic valve regurgitation according to VARC-2 * “NYHA class III or IV” is omitted due to lack of objectiveness in its ascertainment CERC Services CEC eCRF / data-management, CEC Countries Germany, Netherland, Switzerland, United Kingdom Centers number 20 investigational...
PiCSO-AMI-I Brief summary The objective of PiCSO-AMI-I study is to assess efficacy and safety of Pressurecontrolled intermittent Coronary Sinus Occlusion (PiCSO) therapy started post flow restoration but prior to stenting during percutaneous coronary intervention (PCI) compared to standard PCI in the setting of acute STsegment elevation anterior myocardial infarction (STEMI). Primary endpoints Difference in myocardial infarct size (extent of myocardial necrosis quantified by delayed gadolinium enhancement presented as a percentage of LV mass) between the PiCSO Group and the Control Group, assessed by CMR at 5 days post index PCI Major Adverse Cardiac Events at 30 days as well as 6 months and 1, 2 and 3 years post index PCI CERC Services Regulatory submissions, CEC, DSMB CoreLab activities Countries United Kingdom, France, Switzerland Center number 7 investigational...
ACTIVATION Click HERE to read a paper about the results in Cardiovascular News Brief summary Activation is a prospective randomised (1 :1) controlled study to test the hypothesis that revascularisation of significant coronary artery disease by Percutaneous Coronary Intervention prior to Transcatheter Aortic Valve Implantation (TAVI) will result in rate of mortality and re-hospitalisation at 12 months that is non-inferior to TAVI without such revascularisation. Primary endpoints Composite of mortality and rehospitalisation at 12 months CERC Services Clinical trial documentation, Regulatory submissions, Set-up activities, eCRF / data-management, Monitoring, CEC, DSMB, Clinical report Countries France, Germany, United Kingdom Centers number 17 investigational...
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...
