Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease
NCT ID: NCT05701358
Last Updated: 2025-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
5100 participants
INTERVENTIONAL
2023-06-22
2028-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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
Patients randomized to this group will undergo routine staged PCI of all qualifying NCLs that were identified prior to randomization.
Angiography-guided NCL PCI
PCI will be performed as per local practice
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Population Health Research Institute
OTHER
Responsible Party
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Principal Investigators
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Shamir Mehta, MD
Role: PRINCIPAL_INVESTIGATOR
Population Health Research Institute
Locations
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UCLA
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
Cardiovascular Research Institute of Kansas
Wichita, Kansas, United States
The Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Metropolitan Cardiology Consultants / Metropolitan Heart and Vascular Institute (MCC/MHVI)
Coon Rapids, Minnesota, United States
RWJ Barnabas Health
Jersey City, New Jersey, United States
Bassett Medical Center
Cooperstown, New York, United States
VA New York Harbor HealthCare System
New York, New York, United States
NYU Grossman School of Medicine
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
Westmead Hospital
Westmead, New South Wales, Australia
Klinik Floridsdorf
Vienna, , Austria
McGill University Health Centre (MUHC)
Montreal, Quebec, Canada
William Osler Health System
Brampton, , Canada
University of Alberta Hospital, Mazankowski Heart
Edmonton, , Canada
Hamilton Health Sciences
Hamilton, , Canada
Kingston Health Sciences Centre
Kingston, , Canada
St. Mary's General Hospital
Kitchener, , Canada
London Health Sciences Centre
London, , Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, , Canada
Hopital du Sacre-Coeur de Montreal
Montreal, , Canada
Southlake Regional Health Centre
Newmarket, , Canada
Nova Scotia Health
Nova Scotia, , Canada
University of Ottawa Heart Institute
Ottawa, , Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, , Canada
Regina General Hospital
Regina, , Canada
Royal University Hospital
Saskatoon, , Canada
Niagara Health
St. Catharines, , Canada
Newfoundland and Labrador Health Services
St. John's, , Canada
Thunder Bay Regional Health Sciences Centre
Thunder Bay, , Canada
St. Michael's Hospital (Unity Health Toronto)
Toronto, , Canada
Sunnybrook Health Sciences Centre
Toronto, , Canada
Ciusss McQ - Chaur
Trois-Rivières, , Canada
St Paul's Hospital
Vancouver, , Canada
Vancouver General Hospital
Vancouver, , Canada
St. Boniface Hospital
Winnipeg, , Canada
St. Anne's University Hospital
Brno, , Czechia
Aalborg University Hospital
Aalborg, , Denmark
Aarhus University Hospital
Aarhus, , Denmark
Rigshospitalet - Copenhagen University Hospital
Copenhagen, , Denmark
Helsinki University Hospital
Helsinki, , Finland
TAYS Sydankeskus Oy
Tampere, , Finland
Turku University Hospital
Turku, , Finland
St. Vinzenz-Hospital
Cologne, , Germany
Helios Amper-Klinikum
Dachau, , Germany
Universitatsklinikum Frankfurt
Frankfurt, , Germany
Marienkrankenhaus
Hamburg, , Germany
Schoen Klink Hamburg
Hamburg, , Germany
University Heart & Vascular Center Hamburg
Hamburg, , Germany
WKK Heide
Heide, , Germany
Gottsegen National Cardiovascular Center
Budapest, , Hungary
University of Szeged
Szeged, , Hungary
Lisie Hospital
Ernākulam, Kerala, India
Meditrina Hospital
Kollam, Kerala, India
Caritas Hospital Trust
Kottayam, Kerala, India
Apollo Rajshree Hospitals
Indore, Madhya Pradesh, India
Rukmani Birla Hospital
Jaipur, Rajasthan, India
Apollo Hospital
Chennai, Tamil Nadu, India
The Madras Medical Mission
Chennai, Tamil Nadu, India
Meenakshi Mission Hospital and Research Center
Madurai, Tamil Nadu, India
Medicover Hospitals
Hyderabad, , India
Krishna Institute of Medical Sciences
Secunderabad, , India
Azienda USL Toscana Sud Est
Arezzo, , Italy
UOC Cardiologia - Ospedale Maggiore
Bologna, , Italy
Azienda Ospedaliero - Universitaria di Ferrara
Ferrara, , Italy
Misericordia Hospital
Grosseto, , Italy
Azienda USL-IRCCS di Reggio Emilia, Reggio
Reggio Emilia, , Italy
Sant Andrea Hospital - Sapienza University
Rome, , Italy
Sorlandet Hospital Arendal
Kristiansand, Arendal, Norway
Oslo University Hospital Ulleval
Oslo, , Norway
Stavanger University Hospital
Stavanger, , Norway
University Hospital Tromso
Tromsø, , Norway
Provincial Specialized Hospital
Legnica, Lower Silesian Voivodeship, Poland
Miedziowym Centrum Zdrowia S.A. w Lubinie
Lubin, Lower Silesian Voivodeship, Poland
Medical University of Warsaw
Warsaw, Masovian Voivodeship, Poland
Institute for Cardiovascular Diseases Dedinje
Belgrade, , Serbia
University Clinical Center of Serbia
Belgrade, , Serbia
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Ramon y Cajal
Madrid, , Spain
Hospital Universitario de La Princesa
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Virgen del Rocio
Seville, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
Hospital Clinico Universitario de Valladolid
Valladolid, , Spain
Karolinska University Hospital
Huddinge, , Sweden
Lanssjukhuset RYHOV
Jönköping, , Sweden
Karlstad Central Hospital
Karlstad, , Sweden
Skane University Hospital
Lund, , Sweden
Danderyd Hospital
Stockholm, , Sweden
Umeå University Hospital
Umeå, , Sweden
Uppsala University Hospital
Uppsala, , Sweden
East Kent Hospitals University NHS Foundation Trust
Ashford, , United Kingdom
Blackpool Teaching Hospitals
Blackpool, , United Kingdom
Ninewells Hospital
Dundee, , United Kingdom
Harefield Hospital
Harefield, , United Kingdom
Kettering General Hospital
Kettering, , United Kingdom
University Hospitals of Leicester
Leicester, , United Kingdom
Liverpool Heart and Chest Hospital
Liverpool, , United Kingdom
Barts Health NHS Trust
London, , United Kingdom
Imperial College Healthcare NHS Trust
London, , United Kingdom
Royal Free London NHS Foundation Trust
London, , United Kingdom
Manchester University NHS Foundation Trust
Manchester, , United Kingdom
The James Cook University Hospital
Middlesbrough, , United Kingdom
Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Royal Berkshire Foundation NHS Trust
Reading, , United Kingdom
Sheffield Teaching Hospitals
Sheffield, , United Kingdom
East and North Hertfordshire NHS Trust
Stevenage, , United Kingdom
Royal Cornwall Hospitals NHS Trust
Truro, , United Kingdom
The Royal Wolverhampton NHS Trust
Wolverhampton, , United Kingdom
Worcestershire Acute Hospitals NHS Trust
Worcester, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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COMPLETE-2
Identifier Type: -
Identifier Source: org_study_id
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