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Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease

Recruiting

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

1. Patients presenting with STEMI or type 1 NSTEMI and within 72 hours of successful culprit-lesion PCI
2. Residual coronary artery disease defined as at least 1 additional non-infarct-related coronary artery stenosis that meets all of the following criteria:

   1. Amenable to successful treatment with PCI
   2. At least 50% diameter stenosis by visual estimation
   3. At least 2.5 mm in diameter
3. Planned complete revascularization strategy for qualifying MI

Exclusion Criteria:

1. Planned or prior coronary artery bypass graft (CABG) surgery
2. 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
3. Prior PCI of a non-culprit lesion in a different vessel from the culprit lesion within 45 days of randomization
4. Planned medical treatment of all qualifying non-culprit lesions (i.e., no PCI)
5. Presence of severe non-culprit-lesion stenosis with reduced epicardial flow (TIMI flow ≤ 2) or \>90% visual diameter stenosis
6. 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)
7. The only qualifying non-culprit lesion is in the same vessel territory as the culprit lesion
8. 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
9. Non-cardiovascular co-morbidity with expected life expectancy \<2 years
10. Any other medical, geographic, or social factor making study participation impractical or precluding 5 year follow-up

About the study

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.

What is being tested

Sponsor: Population Health Research Institute · Participants: 5,100 · Started: Jun 22, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05701358

Locations in the U.S.

CaliforniaUCLA, Los Angeles
University of California, San Francisco, San Francisco
KansasCardiovascular Research Institute of Kansas, Wichita
MarylandThe Johns Hopkins University School of Medicine, Baltimore
MichiganUniversity of Michigan, Ann Arbor
MinnesotaMetropolitan Cardiology Consultants / Metropolitan Heart and Vascular Institute (MCC/MHVI), Coon Rapids
New JerseyRWJ Barnabas Health, Jersey City
New YorkBassett Medical Center, Cooperstown
NYU Grossman School of Medicine, New York
VA New York Harbor HealthCare System, New York
Montefiore Medical Center, The Bronx
OhioCleveland Clinic, Cleveland
VirginiaUniversity of Virginia Medical Center, Charlottesville

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.