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

Recruiting now · Not applicable

Conditions studied: Acute Myocardial Infarction, Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT05701358

Run by

Population Health Research Institute

People needed

5100

Starts

2023-06-22

Expected to finish

2028-06-01

Last updated by the study team

2025-06-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California, San Francisco — San Francisco, California, United States (enrolling)
• Cardiovascular Research Institute of Kansas — Wichita, Kansas, United States (enrolling)
• The Johns Hopkins University School of Medicine — Baltimore, Maryland, United States (enrolling)
• University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• Metropolitan Cardiology Consultants / Metropolitan Heart and Vascular Institute (MCC/MHVI) — Coon Rapids, Minnesota, United States (enrolling)
• RWJ Barnabas Health — Jersey City, New Jersey, United States (enrolling)
• Bassett Medical Center — Cooperstown, New York, United States (enrolling)
• VA New York Harbor HealthCare System — New York, New York, United States (enrolling)
• NYU Grossman School of Medicine — New York, New York, United States (enrolling)
• Montefiore Medical Center — The Bronx, New York, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• University of Virginia Medical Center — Charlottesville, Virginia, United States (enrolling)
• Westmead Hospital — Westmead, New South Wales, Australia (enrolling)
• Klinik Floridsdorf — Vienna, Austria (enrolling)
• McGill University Health Centre (MUHC) — Montreal, Quebec, Canada (enrolling)
• William Osler Health System — Brampton, Canada (enrolling)
• University of Alberta Hospital, Mazankowski Heart — Edmonton, Canada (enrolling)
• Hamilton Health Sciences — Hamilton, Canada (enrolling)
• Kingston Health Sciences Centre — Kingston, Canada (enrolling)
• St. Mary's General Hospital — Kitchener, Canada (enrolling)
• London Health Sciences Centre — London, Canada (enrolling)
• Centre Hospitalier de l'Universite de Montreal — Montreal, Canada (enrolling)
• Hopital du Sacre-Coeur de Montreal — Montreal, Canada (enrolling)
• Southlake Regional Health Centre — Newmarket, Canada (enrolling)
• UCLA — Los Angeles, California, United States (enrolling)

Full record on ClinicalTrials.gov

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