NCT05701358

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 5,100 (estimated)
• Sponsor: Population Health Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Acute Myocardial Infarction
• Coronary Artery Disease

Interventions

Type	Name	Description
PROCEDURE	Physiology-guided NCL PCI	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.
PROCEDURE	Angiography-guided NCL PCI	PCI will be performed as per local practice

Timeline

• Start date: 2023-06-22
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2023-01-27
• Last updated: 2025-06-19

Locations

113 sites across 17 countries: United States, Australia, Austria, Canada, Czechia, Denmark, Finland, Germany, Hungary, India, Italy, Norway, Poland, Serbia, Spain, Sweden, United Kingdom