Trials

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...

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...

GLYCAR STUDY is a Post Market Multicenter clinical investigation of GLYCAR Bovine pericardial patch with EnCap™ Technology in cardiac and vascular repair or reconstruction surgery. The main objective of this study is to collect real-world, long term clinical data in 100 adult and pediatric patients...

A Prospective, multi-center study to evaluate the safety and performance of the Hyperion™ ASD, PDA and VSD Closure Systems. The purpose of this study is to determine the safety, performance and efficacy of the Hyperion™ Occluder Systems during treatment of ASD, PDA and VSD patients. ClinicalTrials...

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...

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. ClincalTrials.gov ID...

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...