Recruiting

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

Sponsor:

Population Health Research Institute

Code:

NCT05701358

Conditions

Acute Myocardial Infarction

Coronary Artery Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Physiology-guided NCL PCI

Angiography-guided NCL PCI

Study Details

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.

Conditions

Acute Myocardial Infarction

Coronary Artery Disease

Study ID

NCT05701358

Start date

Jun 22, 2023

Status verified date

Jun, 2025

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

5100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

other: Angiography-guided NCL PCI

Patients randomized to this group will undergo routine staged PCI of all qualifying NCLs that were identified prior to randomization.

Interventions

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

Primary outcome measure

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 ]

Central Contacts and Locations

Central contacts

COMPLETE-2 Project Office

(905) 521-2100 complete-2@phri.ca

Locations

UCLA

Recruiting

Los Angeles, California, United States, 90095

Principal Investigator:

Rushi Parikh, MD

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Principal Investigator:

Krishan Soni, MD

Cardiovascular Research Institute of Kansas

Recruiting

Wichita, Kansas, United States, 67226

Principal Investigator:

Bassem Chehab, MD

The Johns Hopkins University School of Medicine

Recruiting

Baltimore, Maryland, United States, 21205

Principal Investigator:

Peter Johnston, MD

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Principal Investigator:

Brett Wanamaker, MD

Metropolitan Cardiology Consultants / Metropolitan Heart and Vascular Institute (MCC/MHVI)

Recruiting

Coon Rapids, Minnesota, United States, 55433

Principal Investigator:

Matthew Whitebeck, MD

RWJ Barnabas Health

Recruiting

Jersey City, New Jersey, United States, 07302

Principal Investigator:

Kimberly Skelding, MD

Bassett Medical Center

Recruiting

Cooperstown, New York, United States, 13326

Principal Investigator:

Dhananjai Menzies, MD

VA New York Harbor HealthCare System

Recruiting

New York, New York, United States, 10010

Principal Investigator:

Binita Shah, MD

NYU Grossman School of Medicine

Recruiting

New York, New York, United States, 10016

Principal Investigator:

Sripal Bangalore, MD

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Principal Investigator:

Mark Menegus, MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Principal Investigator:

Jacqueline Tamis-Holland, MD

University of Virginia Medical Center

Recruiting

Charlottesville, Virginia, United States, 22903

Principal Investigator:

Michael Ragosta, MD

McGill University Health Centre (MUHC)

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Principal Investigator:

Elie Akl, MD

William Osler Health System

Recruiting

Brampton, Canada

Principal Investigator:

Shy Amlani, MD

University of Alberta Hospital, Mazankowski Heart

Recruiting

Edmonton, Canada

Principal Investigator:

Robert Welsh, MD

Hamilton Health Sciences

Recruiting

Hamilton, Canada

Principal Investigator:

Matthew Sibbald, MD

Kingston Health Sciences Centre

Recruiting

Kingston, Canada

Principal Investigator:

Wael Abuzeid, MD

St. Mary's General Hospital

Recruiting

Kitchener, Canada

Principal Investigator:

Hahn Hoe Kim, MD

London Health Sciences Centre

Recruiting

London, Canada

Principal Investigator:

Shahar Lavi, MD

Centre Hospitalier de l'Universite de Montreal

Recruiting

Montreal, Canada

Principal Investigator:

Samer Masour, MD

Hopital du Sacre-Coeur de Montreal

Recruiting

Montreal, Canada

Principal Investigator:

Erick Schampaert, MD

Southlake Regional Health Centre

Recruiting

Newmarket, Canada

Principal Investigator:

Warren Cantor, MD

Nova Scotia Health

Recruiting

Nova Scotia, Canada

Principal Investigator:

Lawrence Title, MD

University of Ottawa Heart Institute

Recruiting

Ottawa, Canada

Principal Investigator:

Derek So, MD

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Recruiting

Québec, Canada

Principal Investigator:

Tomas Cieza, MD

Regina General Hospital

Recruiting

Regina, Canada

Principal Investigator:

Payam Dehghani, MD

Royal University Hospital

Recruiting

Saskatoon, Canada

Principal Investigator:

Jay Shavadia, MD

Niagara Health

Recruiting

St. Catharines, Canada

Principal Investigator:

Natalia Pinilla, MD

Newfoundland and Labrador Health Services

Recruiting

St. John's, Canada

Principal Investigator:

Allison Hall, MD

Thunder Bay Regional Health Sciences Centre

Recruiting

Thunder Bay, Canada

Principal Investigator:

Alexandra Bastiany, MD

St. Michael's Hospital (Unity Health Toronto)

Recruiting

Toronto, Canada

Principal Investigator:

Akshay Bagai, MD

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Canada

Principal Investigator:

Mina Madan, MD

Ciusss McQ - Chaur

Recruiting

Trois-Rivières, Canada

Principal Investigator:

Vincent Spagnoli, MD

St Paul's Hospital

Recruiting

Vancouver, Canada

Principal Investigator:

Robert Boone, MD

Vancouver General Hospital

Recruiting

Vancouver, Canada

Principal Investigator:

David Wood, MD

St. Boniface Hospital

Recruiting

Winnipeg, Canada

Principal Investigator:

Kunal Minhas, MD

More Information

Sponsor

Population Health Research Institute

Last update posted

Jun 19, 2025

Last verified

Jun, 2025

Keywords

NSTEMI
STEMI
multi-vessel disease
optical coherence tomography
FFR
RFR
percutaneous coronary intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Population Health Research Institute on 2025-06-19.