Project

WIN: Worldwide registry to assess the STENTYS XPOSITION S for revascularization of coronary arteries In routine cliNical practice

Completed ยท 2017 until 2020

Type
Clinical Studies
Range
Multicentric, KSSG as participating partner
Units
Status
Completed
Start Date
2017
End Date
2020
Financing
Industry
Study Design
Prospective, non-randomized, multi-center observational registry.
Brief description/objective

To assess the long term safety and efficacy of the XPOSITION S STENT in
routine clinical practice.
Inclusion of subjects with coronary artery disease, including patients with chronic stable angina, silent ischemia and acute coronary syndrome, who qualify for Percutaneous Coronary Interventions (PCI) suitable for a self-expanding drugeluting stent.
Primary endpoints: Target Lesion Failure (TLF), defined as cardiac death, Myocardial Infarction (MI) attributable to the Target Vessel (TV), clinically driven Target Lesion Revascularization (TLR) by percutaneous or surgical methods at 1-year follow-up.
Secondary Endpoints evaluated at each follow-up visit/contact at 1 and 2 years: Target Vessel Failure (TVF); Target Lesion Failure (TLF); Rates for each component of the TLF and TVF composite endpoints;Acute Success Rates; Bleeding or vascular complications at discharge; Stent Thrombosis (ST)