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Clinical Trials in India / NCT05701358
Recruiting Not applicable

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

NCT05701358 · tracked via the Priya Life Science India tracker
Sponsor
Population Health Research Institute
Phase
Not applicable
Started
2023-06-22
Last updated
2025-06-19

Condition(s) studied

Acute Myocardial InfarctionCoronary Artery Disease

Investigational drug(s) / intervention(s)

Physiology-guided NCL PCIAngiography-guided NCL PCI

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: PCI will be performed as per local practice

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (113)

FacilityCityRegionStatus
UCLA Los Angeles California Recruiting
University of California, San Francisco San Francisco California Recruiting
Cardiovascular Research Institute of Kansas Wichita Kansas Recruiting
The Johns Hopkins University School of Medicine Baltimore Maryland Recruiting
University of Michigan Ann Arbor Michigan Recruiting
Metropolitan Cardiology Consultants / Metropolitan Heart and Vascular Institute (MCC/MHVI) Coon Rapids Minnesota Recruiting
RWJ Barnabas Health Jersey City New Jersey Recruiting
Bassett Medical Center Cooperstown New York Recruiting
VA New York Harbor HealthCare System New York New York Recruiting
NYU Grossman School of Medicine New York New York Recruiting
Montefiore Medical Center The Bronx New York Recruiting
Cleveland Clinic Cleveland Ohio Recruiting
University of Virginia Medical Center Charlottesville Virginia Recruiting
Westmead Hospital Westmead New South Wales Recruiting
Klinik Floridsdorf Vienna Austria Recruiting
McGill University Health Centre (MUHC) Montreal Quebec Recruiting
William Osler Health System Brampton Canada Recruiting
University of Alberta Hospital, Mazankowski Heart Edmonton Canada Recruiting
Hamilton Health Sciences Hamilton Canada Recruiting
Kingston Health Sciences Centre Kingston Canada Recruiting
St. Mary's General Hospital Kitchener Canada Recruiting
London Health Sciences Centre London Canada Recruiting
Centre Hospitalier de l'Universite de Montreal Montreal Canada Recruiting
Hopital du Sacre-Coeur de Montreal Montreal Canada Recruiting
Southlake Regional Health Centre Newmarket Canada Recruiting
Nova Scotia Health Nova Scotia Canada Recruiting
University of Ottawa Heart Institute Ottawa Canada Recruiting
Institut Universitaire de Cardiologie et de Pneumologie de Québec Québec Canada Recruiting
Regina General Hospital Regina Canada Recruiting
Royal University Hospital Saskatoon Canada Recruiting
Niagara Health St. Catharines Canada Recruiting
Newfoundland and Labrador Health Services St. John's Canada Recruiting
Thunder Bay Regional Health Sciences Centre Thunder Bay Canada Recruiting
St. Michael's Hospital (Unity Health Toronto) Toronto Canada Recruiting
Sunnybrook Health Sciences Centre Toronto Canada Recruiting
Ciusss McQ - Chaur Trois-Rivières Canada Recruiting
St Paul's Hospital Vancouver Canada Recruiting
Vancouver General Hospital Vancouver Canada Recruiting
St. Boniface Hospital Winnipeg Canada Recruiting
St. Anne's University Hospital Brno Czechia Recruiting

+ 73 more sites — see the full list on the official registry below.

More Population Health Research Institute trials in India

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05701358 on ClinicalTrials.gov ↗ ← All trials in India