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 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 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.
Brief Title
Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease
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.
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.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
(905) 521-2100
Central Contact Email
complete-2@phri.ca
Completion Date
Completion Date Type
Estimated
Conditions
Acute Myocardial Infarction
Coronary Artery Disease
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
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
Inclusion 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
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
Gender
All
Gender Based
false
Keywords
NSTEMI
STEMI
multi-vessel disease
optical coherence tomography
FFR
RFR
percutaneous coronary intervention
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT05701358
Org Class
Other
Org Full Name
Population Health Research Institute
Org Study Id
COMPLETE-2
Overall Status
Recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
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
Primary Outcomes
Outcome Measure
Efficacy: Time to first occurrence of the composite of CV death, new MI, or IDR
Outcome Time Frame
at study completion, a minimum of 2 years
Outcome Measure
Safety: Time to first occurrence of the composite of clinically significant bleeding, stroke, stent thrombosis, or contrast-associated acute kidney injury.
Outcome Time Frame
at study completion, a minimum of 2 years
Secondary Outcomes
Outcome Time Frame
at study completion, a minimum of 2 years
Outcome Measure
Time to first occurrence of the composite of CV death or new MI.
Outcome Time Frame
at study completion, a minimum of 2 years
Outcome Measure
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.
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Mark Menegus
Investigator Email
mmenegus@montefiore.org