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RECRUITING
NCT05701358
NA

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

Sponsor: Population Health Research Institute

View on ClinicalTrials.gov

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.

Official title: A Randomized Trial of Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization Strategies & an Observational Study of Optical Coherence Tomography in Patients With Acute MI & Multivessel Coronary Artery Disease

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

5100

Start Date

2023-06-22

Completion Date

2028-06

Last Updated

2025-06-19

Healthy Volunteers

No

Interventions

PROCEDURE

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.

PROCEDURE

Angiography-guided NCL PCI

PCI will be performed as per local practice

Locations (113)

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