Trials

The Illumina study has been designed to evaluate the efficacy and safety of the new self-expanding polymer free drug eluting stent – NiTiDES – for SFA manufactured by CID S.p.A. member of Alvimedica group. Currently this device represents the first attempt to embed a controlled and targeted drug...

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...

This is a prospective, multi-center, single-arm, open-label, First in Human clinical trial. Clinical follow-up for all patients will be performed at 30 days, 6 months, 1 year after the procedure, and then until 5 years. The enrollment was finalized in June 2023 with a total of 60 subjects were...

IPERF-01 is a prospective, interventional, single arm, longitudinal, monocentric clinical investigation. The objective is to assess the safety of the iPerf femoral arterial cannula in patients undergoing a planned cardiac surgery requiring the use of an extracorporeal circulation via a femoral...

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...

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. ID: NCT04275726

LEADERS-FREE is a randomized double-blinded trial which was designed to assess the combination of a short course (1 month) of DAPT with either the BioFreedom DCS (drug-coated stent) or the Gazelle BMS in patients with at least one of several criteria for an increased bleeding risk: advanced age...

A Prospective Study of the BioFreedom™ Biolimus A9™ Drug Coated Stent in Patients at High Risk for Bleeding Study Details | NCT02843633 | LEADERS FREE II: BioFreedom™ Pivotal Study | ClinicalTrials.gov

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...

Multi-center, Open-label, Prospective, Randomized Study to Show Long-term Efficacy of DCB Treatment With Bail-out BRS in Comparison to BRS Treatment of De-novo Native Coronary Artery Lesions in a Relatively Young PCI Population. The goal of this study is to investigate the equivalence in early and...