Ignite Creation Date:
2024-05-06 @ 9:59 AM
Last Modification Date:
2024-10-26 @ 12:23 PM
Study NCT ID:
NCT03135275
Status:
COMPLETED
Last Update Posted:
2024-01-11
First Post:
2017-04-10
Brief Title:
MULTivessel Immediate Versus STAged RevaScularization in Acute Myocardial Infarction -The MULTISTARS AMI Trial
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
MULTivessel Immediate Versus STAged RevaScularization in Acute Myocardial Infarction - The MULTISTARS AMI Trial
Status:
COMPLETED
Status Verified Date:
2024-01
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:
MULTISTARS AMI
Brief Summary:
The primary objective of the trial is to compare in patients presenting with ST segment elevation myocardial infarction STEMI and multi-vessel disease MVD the safety and efficacy of immediate complete revascularization of all significant coronary lesions versus culprit vessel only revascularization and staged percutaneous coronary intervention PCI of all significant coronary lesions within 19 to 45 days in a non-inferiority trial using a third generation biodegradable-polymer everolimus-eluting stent
Detailed Description:
An investigator-initiated randomized multicenter two-arm open-label study of consecutive patients presenting with STEMI and MVD in stable hemodynamic conditions undergoing after successful PCI of the culprit lesion either 11 randomization immediate revascularization of all additional target lesions during the index procedure or staged PCI of all additional target lesions within 19 to 45 days using the Boston Scientific Synergy stent
The goal of this trial is to compare two treatment strategies that are currently performed in clinical practice immediate complete revascularization versus staged complete revascularization in patients with STEMI and MVD
Patients randomized to immediate complete revascularization will have treated during the index procedure after revascularization of the culprit lesion all significant non-culprit coronary lesions
Patients randomized to staged complete revascularization will have treated during the index procedure only the culprit lesion and they will be hospitalized after 19-45 days for complete revascularization of all significant non-culprit coronary lesions
For both groups lesion are considered significant when causing a 70 diameter stenosis by visual estimation in at least two projections on the coronary angiogram
The goal of this trial is to compare two treatment strategies that are currently performed in clinical practice immediate complete revascularization versus staged complete revascularization in patients with STEMI and MVD
Patients randomized to immediate complete revascularization will have treated during the index procedure after revascularization of the culprit lesion all significant non-culprit coronary lesions
Patients randomized to staged complete revascularization will have treated during the index procedure only the culprit lesion and they will be hospitalized after 19-45 days for complete revascularization of all significant non-culprit coronary lesions
For both groups lesion are considered significant when causing a 70 diameter stenosis by visual estimation in at least two projections on the coronary angiogram
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?:
False
Is an FDA AA801 Violation?:
None