BIOSOLVE IV - Safety and Performance in de Novo Lesions of Native Coronary Arteries with Magmaris
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|
Prospective, single-arm, multicenter, nationwide open label
Planned 200 subjects, with FU at 6, 12, 24 month post-enrolement
|responsible person||Dr. Lucas Jörg|