Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease (COMPLETE-2)
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|ClinicalTrials.gov Identifier: NCT05701358|
Recruitment Status : Recruiting
First Posted : January 27, 2023
Last Update Posted : August 24, 2023
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Myocardial Infarction Coronary Artery Disease||Procedure: Physiology-guided NCL PCI Procedure: Angiography-guided NCL PCI||Not Applicable|
COMPLETE-2 STUDY OBJECTIVES
- 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).
- 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 (Clinical Trial)|
|Estimated Enrollment :||5100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Actual Study Start Date :||June 22, 2023|
|Estimated Primary Completion Date :||June 2028|
|Estimated Study Completion Date :||June 2028|
Active Comparator: Physiology-guided Non-Culprit-Lesion (NCL) PCI
Patients randomized to this group will have their physiology assessment using RFR and/or FFR of all qualifying NCLs that were identified prior to randomization. Other validated non-hyperemic physiology ratios (eg. iFR) may only be used when RFR is not available.
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.
Angiography-guided NCL PCI
Patients randomized to this group will undergo routine staged PCI of all qualifying NCLs that were identified prior to randomization.
Procedure: Angiography-guided NCL PCI
PCI will be performed as per local practice
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05701358
|Contact: COMPLETE-2 Project Office||(905) email@example.com|
|Hamilton Health Sciences||Recruiting|
|Contact: Matthew Sibbald, MD|
|Principal Investigator:||Shamir Mehta, MD||Population Health Research Institute|