Coronary Artery Disease Clinical Trial
Official title:
BIOTRONIK - Safety and Clinical Performance Of the Magmaris Drug Eluting Absorbable Metal Scaffold in a Cohort of Patients in India With de Novo Lesions in NatiVE Coronary Arteries
Assessment of the clinical performance and the safety of the Magmaris Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold in a cohort of patients in India with de novo coronary artery lesions.
This is a prospective, multi-centre, single-arm, open label trial to assess the safety and
clinical performance of Magmaris Drug Eluting Absorbable Metal Scaffold.
A total of up to 110 patients with de novo lesions in native coronary arteries will be
enrolled at up to 8 investigational sites in India.
In-hospital clinical follow-up visits will take place at 1 and 6 months post procedure.
The primary endpoint is target lesion failure (a composite of cardiac death, target vessel
Q-wave or non-Q wave myocardial infarction, coronary artery bypass grafting, clinically
driven target lesion revascularization) at 1 month post procedure.
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