Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around
Principal Investigator
by Rushi Parikh, MD

Description

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.

Official Title

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

Details

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 efficacy composite outcome of cardiovascular (CV) death, new myocardial infarction (MI) or ischemia-driven revascularization (IDR).
  2. To determine whether a physiology-guided complete revascularization strategy is superior to an angiography-guided complete revascularization strategy in reducing the safety composite outcome of clinically significant bleeding, stroke, stent thrombosis or contrast-associated acute kidney injury.

Keywords

Acute Myocardial Infarction, Coronary Artery Disease, NSTEMI, STEMI, multi-vessel disease, optical coherence tomography, FFR, RFR, percutaneous coronary intervention, Myocardial Ischemia, Coronary Disease, Myocardial Infarction, Infarction, Physiology-guided NCL PCI, Angiography-guided NCL PCI, Physiology-guided Non-Culprit-Lesion (NCL) PCI

Eligibility

You can join if…

Open to people ages 18 years and up

  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 CAN'T join 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
  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

Locations

  • UCLA accepting new patients
    Los Angeles California 90095 United States
  • University of Calgary - Foothills Medical Centre accepting new patients
    Calgary Canada

Lead Scientist at UCLA

  • Rushi Parikh, MD
    Hs Associate Clinical Professor, Medicine. Authored (or co-authored) 60 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Population Health Research Institute
ID
NCT05701358
Study Type
Interventional
Participants
Expecting 5100 study participants
Last Updated