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RecruitingAcute Myocardial InfarctionCoronary Artery Disease

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

Eligible age

18+ yrs

Accepts

All genders

Locations

9 states

Healthy volunteers

No

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About this 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.

Sponsor: Population Health Research Institute

You may qualify if…

  • 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

You may not qualify if…

  • 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

Where it's recruiting

California

Los Angeles · San Francisco

Kansas

Wichita

Maryland

Baltimore

Michigan

Ann Arbor

Minnesota

Coon Rapids

New Jersey

Jersey City

New York

Cooperstown · New York · The Bronx

Ohio

Cleveland

Virginia

Charlottesville

Source: ClinicalTrials.gov · NCT05701358 · last updated 2025-06-19

Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Re · TrialPath