landmark trial Sponsor Name : Meril Life Sciences Pvt.Ltd. Brief summary Landmark Trial is a prospective, randomized, multinational, multicentric, open-label non-inferiority trial of approximately 768 subjects (384:384, Myval THV Series vs. Contemporary Valves) with severe symptomatic native aortic valve stenosis via transfemoral approach. Primary Combined safety and effectiveness Endpoint(s): [Time frame: 30 days] Conduction system disturbances resulting in a new permanent pacemaker implantation. Secondary Endpoint(s) related to the corelab analyses 1) The combined safety and effectiveness endpoint: [Time frame: 1-year] 2) New permanent pacemaker implantation [Time Frame: baseline, Pre-discharge, 30-days,1-year and 5-years] – New permanent pacemaker implantation rates will be analyzed further based on the patient’s history of left and/or right bundle branch block. 3) Conduction disturbances and arrhythmias according to VARC-2 [Time Frame: baseline, Pre-discharge, 30-days,1-year and 5-years] 4) New onset of atrial fibrillation or atrial flutter [Time Frame: Pre-discharge, 30-days, 1-year and 5-years] 5) Major Q-QS abnormalities according to Minnesota Code manual of ECG findings at baseline, pre-discharge, 6 months and 1year follow-up CERC Services CoreLab activities Countries 67 European...
ALL women Sponsor Name : CERIC (investigator initiated trial) Grant Giver: Biosensors international Brief summary All Women study is a unique newly launching randomized controlled trial targeting female population older than 75 years old with symptomatic aortic stenosis. The objective is to demonstrate lower mean gradient by Echo 30 days after TAVI procedure with Allegra (Biosensors), versus patients treated by balloon expandable TAVI. Primary endpoints Trans-aortic mean gradient 30 days after transcatheter valve implantation procedure, measured by transthoracic echocardiography CERC Services Submission to competent authorities and ethic committees Contract and payment management for hospitals EDC setup and data management, monthly report SIV and monitoring Corelab –echo analysis Statistical activities CEC meeting Safety activities (MedDRA coding, annual report) Clinical study report (final and primary endpoint) Countries 7 countries (tentative) in Europe Number of investigational sites: 12 centers (tentative) Number of patients 130...
selution denovo Sponsor Name MedAlliance Brief summary A Prospective Randomized (1:1), Multi-center, International, Open label Clinical trial. The objective is to demonstrate non-inferiority for Target Vessel Failure (TVF) of a treatment strategy with first line SELUTION SLR Drug Eluting Balloon (DEB) plus provisional Drug Eluting Stent (DES) vs. systematic treatment with DES for the treatment of de novo coronary lesions, at 1 year and 5 years. Primary endpoints Target Vessel Failure (cardiac death, target-vessel related myocardial infarction (MI) or clinically driven target vessel revascularization (cd-Target Vessel Revascularization)) at 1 year Target Vessel Failure at 5 years CERC Services Regulatory submissions, Project management, Monitoring management, Data management; Core Laboratory, Safety activities; Statistical activities, CEC and DSMB activities; and Final Clinical Report Countries Up to 15 countries: Austria, Czech Republic, Finland, France, Germany, Italy, Poland, Singapore, Switzerland, UK (pending confirmation for Malaysia, Spain, Taiwan, The Netherlands) Number of investigational sites: Up to 80 sites (41 activated sites, submissions ongoing) Number of patients: 3326...
REVERSE STUDY Sponsor Name B.BRAUN MELSUNGEN AG AESCULAP DIVISION Brief summary REVERSE study is a prospective, randomised, open-label, international multicenter trial to evaluate the safety and efficacy of drug-coated balloon (DCB) treatment compared to drug-eluting stenting (DES) in patients with large coronary artery disease. The objective is to compare the safety and efficacy of drug-coated balloon treatment and drug-eluting stenting in patients with large coronary artery disease. The objective is to enroll 1436 patients eligible for PCI at 19-21 investigational sites and patients will be followed up to 3 years after procedure. Primary endpoints The primary endpoint is the occurrence within 1 year of net adverse clinical event (NACE), a composite of all-cause death, non-fatal myocardial infarction, clinically driven target vessel revascularization, or major bleeding (BARC type 3 to 5). CERC Services Clinical trial documentation, Regulatory Submission, Set-up activities (sites feasibility, contract management), Project Management, Monitoring, Safety reporting, Statistical Analysis Clinical report Countries South Korea, Malaysia, Singapore, and Taiwan. Number of investigational sites: 19-21 sites Number of patients:...
PINNACLE I STUDY Sponsor Name Elixir Medical Corporation Summary This is a prospective, multicenter, single-arm clinical study. The objective is to enroll up to 60 patients requiring percutaneous coronary intervention (PCI) on up to two de novo coronary artery lesions with reference vessel diameters ≥ 2.25 mm and ≤ 3.5 mm, and lesion lengths of ≤ 34 mm, with moderate to severe calcification. Up to two de novo moderately to severely calcified coronary artery lesions located in separate epicardial vessels (RCA, LCX or LAD) which meet the inclusion/exclusion criteria may be treated with the LithiX Coronary HCLC to prepare the lesion prior to stenting. All patients will undergo coronary angiography to assess the final residual stenosis immediately post-LithiX Coronary HCLC treatment and post stenting. In the Optical Coherence Tomography (OCT) imaging subgroup, approximately 30 patients will undergo OCT imaging at pre-procedure, post-LithiX Coronary HCLC treatment, and the end of procedure following stent deployment. All angiographic and OCT images will be analyzed by the independent core laboratory. Stent implantation is performed per standard practice. Subjects will be followed through hospital discharge and will have clinical follow-up conducted by phone at 30 days and 6 months post-index procedure. Objectives & Primary endpoints The objective of to assess safety and performance of the LithiX Coronary HCLC to treat moderately to severely calcified coronary artery lesions by percutaneous transluminal coronary angioplasty (PTCA). The primary safety endpoint is the major adverse cardiovascular events (MACE) through 30 days. MACE is defined as a per-subject composite endpoint of cardiovascular death, myocardial infarction, and target vessel revascularization. The primary performance endpoint is the clinical success defined...
nagomi complex PMCF Sponsor : Terumo Europe Brief summary Nagomi Complex PMCF is a Post-Market Clinical Follow-up Study with Ultimaster NagomiTM Sirolimus Eluting Coronary Stent System in Complex PCI Subjects 3,000 Complex subjects eligible for a percutaneous coronary intervention are enrolled in the study. Quantitative Coronary Angiography (QCA) will be performed for angiograms of the index procedure for a subset of 600 subjects with a bifurcation lesion. Primary Endpoint The primary endpoint is Target Lesion Failure (TLF) defined as the composite of cardiovascular death, target-vessel related myocardial infarction and clinically driven target lesion revascularization at 1-year post-procedure. CERC Services CoreLab activities Countries Up to 60 sites in...
