BIOSOLVE IV - Safety and Performance in de Novo Lesions of Native Coronary Arteries with Magmaris - Projekt

Projekt

BIOSOLVE IV - Safety and Performance in de Novo Lesions of Native Coronary Arteries with Magmaris

Abgebrochen · 2018 bis 2022

Jörg Lucas, Schneider Irene

Art

Klinische Forschung

Reichweite

Multizentrisch, KSSG als teilnehmendes Zentrum

Bereiche

Kardiologie

Status

Abgebrochen

Start

2018

Ende

2022

Finanzierungsart

Industrie

Studiendesign

Prospective, single-arm, multicenter, nationwide open label registry. Planned 200 subjects, with FU at 6, 12, 24 month post-enrolement

Kurzbeschreibung/Zielsetzung

The aim of the BIOSOLVE - IV Swiss Satellite Registry is to investigate the clinical performance and long-term safety of Magmaris in a real world setting and extend clinical practice using the technology in a monitored nationwide registry.
Primary Endpoint: Target Lesion Failure as a composite of cardiac death, target vessel Q-wave or non-Q wave Myocardial Infarction or clinically driven Target Lesion Revascularization within 12 months.
Main inclusion criteria: symptomatic coronary artery disease, a maximum of two single de novo lesions in two different vessels, TIMI >=1, eligible for DAPT.
Main exclusion criteria: STEMI, calcified, tortuos, restenotic, left main lesions, bifurcations, Thrombus, LVEF <= 30%, dialyses etc.