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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
5,100
For RFR, PCI will be performed as per local practice for all lesions with RFR ≤0.89. For FFR, PCI will be performed as per local practice for all NCLs with FFR ≤0.80.
PCI will be performed as per local practice
UCLA
Los Angeles, California, United States
RECRUITINGUniversity of California, San Francisco
San Francisco, California, United States
RECRUITINGCardiovascular Research Institute of Kansas
Wichita, Kansas, United States
RECRUITINGThe Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Efficacy: Time to first occurrence of the composite of CV death, new MI, or IDR
Time frame: at study completion, a minimum of 2 years
Safety: Time to first occurrence of the composite of clinically significant bleeding, stroke, stent thrombosis, or contrast-associated acute kidney injury.
Time frame: at study completion, a minimum of 2 years
Time to first occurrence of the composite of CV death or new MI.
Time frame: at study completion, a minimum of 2 years
Net clinical outcome: Time to first occurrence of the composite of CV death, new MI, clinically significant bleeding, stroke, stent thrombosis or contrast-associated acute kidney injury.
Time frame: at study completion, a minimum of 2 years
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University of Michigan
Ann Arbor, Michigan, United States
RECRUITINGMetropolitan Cardiology Consultants / Metropolitan Heart and Vascular Institute (MCC/MHVI)
Coon Rapids, Minnesota, United States
RECRUITINGRWJ Barnabas Health
Jersey City, New Jersey, United States
RECRUITINGBassett Medical Center
Cooperstown, New York, United States
RECRUITINGVA New York Harbor HealthCare System
New York, New York, United States
RECRUITINGNYU Grossman School of Medicine
New York, New York, United States
RECRUITING...and 103 more locations