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

Lucas Jörg & Irene Schneider

abstract 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.
   
type of project clinical studies
status ongoing - recruiting phase
start of project 2018
end of project 2022
study design Prospective, single-arm, multicenter, nationwide open label registry.
Planned 200 subjects, with FU at 6, 12, 24 month post-enrolement
responsible person Dr. Lucas Jörg