Status:

RECRUITING

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

Lead Sponsor:

Population Health Research Institute

Conditions:

Acute Myocardial Infarction

Coronary Artery Disease

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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...

Detailed Description

COMPLETE-2 STUDY OBJECTIVES 1. To determine whether a strategy of physiology-guided complete revascularization is non-inferior to a strategy of angiography-guided complete revascularization on the ef...

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

Key Trial Info

Start Date :

June 22 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2028

Estimated Enrollment :

5100 Patients enrolled

Trial Details

Trial ID

NCT05701358

Start Date

June 22 2023

End Date

June 1 2028

Last Update

June 19 2025

Active Locations (113)

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Page 1 of 29 (113 locations)

1

UCLA

Los Angeles, California, United States, 90095

2

University of California, San Francisco

San Francisco, California, United States, 94143

3

Cardiovascular Research Institute of Kansas

Wichita, Kansas, United States, 67226

4

The Johns Hopkins University School of Medicine

Baltimore, Maryland, United States, 21205

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