Ignite Creation Date:
2024-05-06 @ 10:21 AM
Last Modification Date:
2024-10-26 @ 12:28 PM
Study NCT ID:
NCT03234348
Status:
COMPLETED
Last Update Posted:
2020-04-17
First Post:
2017-07-24
Brief Title:
MAGnesium-based Bioresorbable Scaffold in ST Segment Elevation Myocardial Infarction
Sponsor:
Hospital Clinic of Barcelona
Organization:
Hospital Clinic of Barcelona
Study Overview
Official Title:
MAGnesium-based Bioresorbable Scaffold and Vasomotor Function in Patients With Acute ST Segment Elevation Myocardial Infarction
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MAGSTEMI
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None