Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute M… (NCT05701358) | Clinical Trial Compass
RecruitingNot Applicable
Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease
United States5,100 participantsStarted 2023-06-22
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients presenting with STEMI or type 1 NSTEMI and within 72 hours of successful culprit-lesion PCI
✓. Residual coronary artery disease defined as at least 1 additional non-infarct-related coronary artery stenosis that meets all of the following criteria:
✓. Amenable to successful treatment with PCI
✓. At least 50% diameter stenosis by visual estimation
✓. At least 2.5 mm in diameter
✓. Planned complete revascularization strategy for qualifying MI
Exclusion criteria
✕. Planned or prior coronary artery bypass graft (CABG) surgery
✕. 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
✕. Prior PCI of a non-culprit lesion in a different vessel from the culprit lesion within 45 days of randomization
What they're measuring
1
Efficacy: Time to first occurrence of the composite of CV death, new MI, or IDR
Timeframe: at study completion, a minimum of 2 years
2
Safety: Time to first occurrence of the composite of clinically significant bleeding, stroke, stent thrombosis, or contrast-associated acute kidney injury.
Timeframe: at study completion, a minimum of 2 years
. Planned medical treatment of all qualifying non-culprit lesions (i.e., no PCI)
✕. Presence of severe non-culprit-lesion stenosis with reduced epicardial flow (TIMI flow ≤ 2) or \>90% visual diameter stenosis
✕. 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)
✕. The only qualifying non-culprit lesion is in the same vessel territory as the culprit lesion
✕. 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