Project
BIOSOLVE IV - Safety and Performance in de Novo Lesions of Native Coronary Arteries with Magmaris
Aborted · 2018 until 2022
Jörg Lucas, Schneider Irene
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Brief description/objective
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.