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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPopulation Health Research Institute

About this trial

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.

Eligibility criteria

Qualifiers

Patients presenting with STEMI or type 1 NSTEMI and within 72 hours of successful culprit-lesion PCI

Amenable to successful treatment with PCI

At least 50% diameter stenosis by visual estimation

At least 2.5 mm in diameter

Disqualifiers

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

Planned medical treatment of all qualifying non-culprit lesions (i.e., no PCI)

Trial design

Treatments tested in this trial

  • Physiology-guided NCL PCI
  • Angiography-guided NCL PCI

Treatment groups

5,100 Participants
are divided into 2 treatment groups

Locations

113
Australia
Westmead Hospital WestmeadNew South Wales, Australia
Austria
Klinik Floridsdorf Vienna Austria
Canada
McGill University Health Centre (MUHC)H4A 3J1, MontrealQuebec, Canada
William Osler Health System Brampton Canada

Sponsors and collaborators

Population Health Research Institute

Lead sponsor