Status:
RECRUITING
Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease
Lead Sponsor:
Population Health Research Institute
Conditions:
Acute Myocardial Infarction
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 ef...
Eligibility Criteria
Inclusion Criteria:
-
Patients presenting with STEMI or type 1 NSTEMI and within 72 hours of successful culprit-lesion PCI
-
Residual coronary artery disease defined as at least 1 additional non-infarct-related coronary artery stenosis that meets all of the following criteria:
- Amenable to successful treatment with PCI
- At least 50% diameter stenosis by visual estimation
- At least 2.5 mm in diameter
-
Planned complete revascularization strategy for qualifying MI
Exclusion Criteria:
- Planned or prior coronary artery bypass graft (CABG) surgery
- Inability to clearly identify a culprit lesion for STEMI or NSTEMI based on angiographic appearance and/or ECG changes and/or regional wall motion abnormalities
- Prior PCI of a non-culprit lesion in a different vessel from the culprit lesion within 45 days of randomization
- Planned medical treatment of all qualifying non-culprit lesions (i.e., no PCI)
- Presence of severe non-culprit-lesion stenosis with reduced epicardial flow (TIMI flow ≤ 2) or >90% visual diameter stenosis
- Presence of a chronic total occlusion (CTO) if it is the only qualifying non-culprit lesion (patients with a CTO plus additional qualifying non-culprit lesions are eligible)
- The only qualifying non-culprit lesion is in the same vessel territory as the culprit lesion
- Baseline STEMI or NSTEMI was due to a suspected non-atherothrombotic mechanism such as type 2 MI (supply-demand mismatch), including spontaneous coronary artery dissection or coronary artery embolism
- Non-cardiovascular co-morbidity with expected life expectancy <2 years
- Any other medical, geographic, or social factor making study participation impractical or precluding 5 year follow-up
Key Trial Info
Start Date :
June 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
5100 Patients enrolled
Trial Details
Trial ID
NCT05701358
Start Date
June 22 2023
End Date
June 1 2028
Last Update
June 19 2025
Active Locations (113)
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1
UCLA
Los Angeles, California, United States, 90095
2
University of California, San Francisco
San Francisco, California, United States, 94143
3
Cardiovascular Research Institute of Kansas
Wichita, Kansas, United States, 67226
4
The Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21205