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.
Trancrocetins (TCs) have been reported to possess the capabilities to increase the diffusion of oxygen in plasma or water. Developed as a liposomal formulation of TC, LEAF-4L6715 allows for a gradual release of the free drug and was evaluated at multiple levels. A phase 1/2 trial including 37...
LVAD Corheart6 is a single arm, prospective, open label and multicenter pre-market study. The objective is to to evaluate the safety and effectiveness of the Corheart 6 VAS when used for the treatment of advanced, refractory heart failure in an European population. The objective is to enroll 50...
MAGICAL SV is a prospective, multi-center, multinational, randomized, single-blind, pivotal, 2-arm parallel groups study. The objective is to evaluate the safety and efficacy of the MagicTouchTM Drug coated balloon in treatment of small vessels (≤2.75 mm) in patients with coronary artery disease. A...
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...
OPTIXIENCE is an observational, international, multicentre and prospective study that aims 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 purpose of this study is to collect and monitor ongoing safety and performance clinical data of the ACURATE neo2™ aortic bioprosthesis and the ACURATE neo2™ transfemoral delivery system, in the context of an observational investigator-initiated trial (IIT). There are no additional and/or...
Single-arm, open-label, multi-center subject Registry of the R-OneTM system to evaluate its real-world performance and safety during PCI, from the start of the procedure and until hospital discharge. Post-Market Clinical Follow-up study
RADIUS-HTN study is a prospective, multi-center, international, post-market, randomized (1:1) clinical trial in patients with uncontrolled hypertension. The objective is to compare the safety and efficacy of radio frequency renal denervation using the Iberis Renal Denervation System (AngioCare) via...
RE-ADAPT-HF is a prospective, multicenter, randomized, blinded, sham-controlled, feasibility study of renal denervation in patients with chronic heart failure. Randomisation (1:1; Renal Denervation: Sham) of approximately 144 subjects (72 in each arm).
