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Comparing two methods for complete heart artery treatment after a heart attack

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

Not applicable Interventional Population Health Research Institute · NCT05701358

This study is testing whether a new way of treating heart arteries after a heart attack can help people with multiple blocked arteries do better than the usual method.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment5100 (estimated)
Ages18 Years and up
SexAll
SponsorPopulation Health Research Institute Academic / other
Locations113 sites (Los Angeles, California and 112 other locations)
Trial IDNCT05701358 on ClinicalTrials.gov

What this trial studies

The COMPLETE-2 trial is a prospective, multi-centre, randomized controlled trial that evaluates the effectiveness of physiology-guided complete revascularization versus angiography-guided complete revascularization in patients who have experienced an acute myocardial infarction (MI) and have multivessel coronary artery disease. Participants will have undergone successful treatment of the culprit lesion through Percutaneous Coronary Intervention (PCI) within 72 hours of their MI. The study aims to determine if the physiology-guided approach is as effective or superior in reducing cardiovascular events and complications compared to the traditional angiography-guided method.

Who should consider this trial

Good fit: Ideal candidates are patients presenting with STEMI or type 1 NSTEMI who have undergone successful PCI and have additional non-infarct-related coronary artery stenosis.

Not a fit: Patients who have planned or prior coronary artery bypass graft surgery or those who cannot identify a culprit lesion may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for patients with acute myocardial infarction and multivessel disease, potentially reducing the risk of future heart events.

How similar studies have performed: Other studies have shown promising results with similar approaches, indicating that this methodology is not entirely novel but still holds significant potential for advancement.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Los Angeles, California and 112 other locations

+63 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Myocardial InfarctionCoronary Artery DiseaseNSTEMISTEMImulti-vessel diseaseoptical coherence tomographyFFRRFR
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.