Acute Coronary Syndrome Clinical Trial
Official title:
MAGnesium-based Bioresorbable Scaffold and Vasomotor Function in Patients With Acute ST Segment Elevation Myocardial Infarction
This is a prospective, randomized, active control, single-blind, non-inferiority, multicenter
clinical trial. 148 subjects will be registered at up to 10 Spanish sites. Subjects will be
followed for 5 years.
All eligible patients (STEMI < 12 hours from onset of chest pain) will be randomized to
- Biotronik MAGMARISTM Sirolimus Eluting Bioresorbable Vascular Scaffold System (M-BRS) or
- Biotronik ORSIRO Sirolimus Eluting Coronary Stent System
Endothelium-independent vasomotor response (NTG injection) will be analyzed at 12 months
angiographic follow-up (Primary endpoint).
In a subgroup of 40 patients Optical Coherence Tomography will be performed after the
procedure and at 12 months follow-up.
Angiographic (QCA pre- and post-procedure and at 12 months follow-up), OCT data (at 12 months
follow-up) will be analyzed off-line by an independent core lab.
n/a
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