Projekt

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

Abgeschlossen · 2017 bis 2020

Art
Klinische Forschung
Reichweite
Multizentrisch, KSSG als teilnehmendes Zentrum
Bereiche
Status
Abgeschlossen
Start
2017
Ende
2020
Finanzierungsart
Industrie
Studiendesign
Prospective, non-randomized, multi-center observational registry.
Kurzbeschreibung/Zielsetzung

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)