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NCT05701358NARecruiting

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

Population Health Research Institute

Start Date

6/22/2023

Completion Date

6/1/2028

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.

Detailed Description

COMPLETE-2 STUDY OBJECTIVES 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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

PROCEDURE

Physiology-guided NCL PCI

PROCEDURE

Angiography-guided NCL PCI

Interested in This Trial?

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Conditions

Acute Myocardial InfarctionCoronary Artery Disease

Locations

UCLA

Los Angeles, California 90095

United States

University of California, San Francisco

San Francisco, California 94143

United States

Cardiovascular Research Institute of Kansas

Wichita, Kansas 67226

United States

The Johns Hopkins University School of Medicine

Baltimore, Maryland 21205

United States

University of Michigan

Ann Arbor, Michigan 48109

United States

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

Coon Rapids, Minnesota 55433

United States

RWJ Barnabas Health

Jersey City, New Jersey 07302

United States

Bassett Medical Center

Cooperstown, New York 13326

United States

VA New York Harbor HealthCare System

New York, New York 10010

United States

NYU Grossman School of Medicine

New York, New York 10016

United States

Montefiore Medical Center

The Bronx, New York 10467

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

University of Virginia Medical Center

Charlottesville, Virginia 22903

United States

Westmead Hospital

Westmead, New South Wales

Australia

Klinik Floridsdorf

Vienna,

Austria

McGill University Health Centre (MUHC)

Montreal, Quebec H4A 3J1

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