Ignite Creation Date:
2024-05-06 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05701358
Status:
RECRUITING
Last Update Posted:
2024-02-15
First Post:
2023-01-17
Brief Title:
Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI Multivessel Disease
Sponsor:
Population Health Research Institute
Organization:
Population Health Research Institute
Study Overview
Official Title:
A Randomized Trial of Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization Strategies an Observational Study of Optical Coherence Tomography in Patients With Acute MI Multivessel Coronary Artery Disease
Status:
RECRUITING
Status Verified Date:
2024-02
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:
COMPLETE-2
Brief Summary:
COMPLETE-2 is a prospective multi-centre randomized controlled trial comparing a strategy of physiology-guided complete revascularization to angiography-guided complete revascularization in patients with acute ST-segment elevation myocardial infarction STEMI or non-ST-segment elevation myocardial infarction NSTEMI and multivessel coronary artery disease CAD who have undergone successful culprit lesion Percutaneous Coronary Intervention PCI
COMPLETE-2 OCT is a large scale prospective multi-centre observational imaging study of patients with STEMI or NSTEMI and multivessel CAD in a subset of eligible COMPLETE-2 patients
COMPLETE-2 OCT is a large scale prospective multi-centre observational imaging study of patients with STEMI or NSTEMI and multivessel CAD in a subset of eligible COMPLETE-2 patients
Detailed Description:
COMPLETE-2 STUDY OBJECTIVES
1 To determine whether a strategy of physiology-guided complete revascularization is non-inferior to a strategy of angiography-guided complete revascularization on the efficacy composite outcome of cardiovascular CV death new myocardial infarction MI or ischemia-driven revascularization IDR
2 To determine whether a physiology-guided complete revascularization strategy is superior to an angiography-guided complete revascularization strategy in reducing the safety composite outcome of clinically significant bleeding stroke stent thrombosis or contrast-associated acute kidney injury
1 To determine whether a strategy of physiology-guided complete revascularization is non-inferior to a strategy of angiography-guided complete revascularization on the efficacy composite outcome of cardiovascular CV death new myocardial infarction MI or ischemia-driven revascularization IDR
2 To determine whether a physiology-guided complete revascularization strategy is superior to an angiography-guided complete revascularization strategy in reducing the safety composite outcome of clinically significant bleeding stroke stent thrombosis or contrast-associated acute kidney injury
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