|

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

RECRUITINGN/ASponsored by Population Health Research Institute
Actively Recruiting
PhaseN/A
SponsorPopulation Health Research Institute
Started2023-06-22
Est. completion2028-06
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations13 sites
View on ClinicalTrials.gov →

NCT05701358

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 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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions3

Acute Myocardial InfarctionCoronary Artery DiseaseHeart Disease

Locations13 sites

UCLA
Los Angeles, California, 90095
Rushi Parikh, MD
University of California, San Francisco
San Francisco, California, 94143
Krishan Soni, MD
Cardiovascular Research Institute of Kansas
Wichita, Kansas, 67226
Bassem Chehab, MD
The Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205
Peter Johnston, MD
University of Michigan
Ann Arbor, Michigan, 48109
Brett Wanamaker, MD

Browse More Trials

Heart Disease trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.