NCT03234348

MAGnesium-based Bioresorbable Scaffold in ST Segment Elevation Myocardial Infarction

MAGnesium-based Bioresorbable Scaffold and Vasomotor Function in Patients With Acute ST Segment Elevation Myocardial Infarction

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Acute Coronary Syndrome
• ST Segment Elevation Myocardial Infarction
• Stent

Interventions

Type	Name	Description
DEVICE	Percutaneous coronary intervention	PCI + stent implantation

Timeline

• Start date: 2017-07-01
• Primary completion: 2019-06-30
• Completion: 2019-10-31
• First posted: 2017-07-31
• Last updated: 2020-04-17

Locations

11 sites across 1 country: Spain