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

Last updated: June 16, 2025
Sponsor: Population Health Research Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Disease

Atherosclerosis

Hypercholesterolemia

Treatment

Physiology-guided NCL PCI

Angiography-guided NCL PCI

Clinical Study ID

NCT05701358
COMPLETE-2
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  1. Patients presenting with STEMI or type 1 NSTEMI and within 72 hours of successfulculprit-lesion PCI

  2. Residual coronary artery disease defined as at least 1 additionalnon-infarct-related coronary artery stenosis that meets all of the followingcriteria:

  3. Amenable to successful treatment with PCI

  4. At least 50% diameter stenosis by visual estimation

  5. At least 2.5 mm in diameter

  6. Planned complete revascularization strategy for qualifying MI

Exclusion

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 onangiographic 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 lesionwithin 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 (TIMIflow ≤ 2) or >90% visual diameter stenosis

  6. Presence of a chronic total occlusion (CTO) if it is the only qualifying non-culpritlesion (patients with a CTO plus additional qualifying non-culprit lesions areeligible)

  7. The only qualifying non-culprit lesion is in the same vessel territory as theculprit lesion

  8. Baseline STEMI or NSTEMI was due to a suspected non-atherothrombotic mechanism suchas type 2 MI (supply-demand mismatch), including spontaneous coronary arterydissection 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 participationimpractical or precluding 5 year follow-up

Study Design

Total Participants: 5100
Treatment Group(s): 2
Primary Treatment: Physiology-guided NCL PCI
Phase:
Study Start date:
June 22, 2023
Estimated Completion Date:
June 30, 2028

Study 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.

Connect with a study center

  • Westmead Hospital

    Westmead, New South Wales
    Australia

    Active - Recruiting

  • Klinik Floridsdorf

    Vienna,
    Austria

    Active - Recruiting

  • McGill University Health Centre (MUHC)

    Montréal, Quebec H4A 3J1
    Canada

    Active - Recruiting

  • William Osler Health System

    Brampton,
    Canada

    Active - Recruiting

  • University of Calgary - Foothills Medical Centre

    Calgary,
    Canada

    Site Not Available

  • University of Alberta Hospital, Mazankowski Heart

    Edmonton,
    Canada

    Active - Recruiting

  • Hamilton Health Sciences

    Hamilton,
    Canada

    Active - Recruiting

  • Kingston Health Sciences Centre

    Kingston,
    Canada

    Active - Recruiting

  • St. Mary's General Hospital

    Kitchener,
    Canada

    Active - Recruiting

  • London Health Sciences Centre

    London,
    Canada

    Active - Recruiting

  • Centre Hospitalier de l'Universite de Montreal

    Montréal,
    Canada

    Active - Recruiting

  • Hopital du Sacre-Coeur de Montreal

    Montréal,
    Canada

    Active - Recruiting

  • Southlake Regional Health Centre

    Newmarket,
    Canada

    Active - Recruiting

  • Nova Scotia Health

    Nova Scotia,
    Canada

    Active - Recruiting

  • University of Ottawa Heart Institute

    Ottawa,
    Canada

    Active - Recruiting

  • Institut Universitaire de Cardiologie et de Pneumologie de Québec

    Québec,
    Canada

    Active - Recruiting

  • Regina General Hospital

    Regina,
    Canada

    Active - Recruiting

  • Royal University Hospital

    Saskatoon,
    Canada

    Active - Recruiting

  • Niagara Health

    St. Catharines,
    Canada

    Active - Recruiting

  • Newfoundland and Labrador Health Services

    St. John's,
    Canada

    Active - Recruiting

  • Thunder Bay Regional Health Sciences Centre

    Thunder Bay,
    Canada

    Active - Recruiting

  • St. Michael's Hospital (Unity Health Toronto)

    Toronto,
    Canada

    Active - Recruiting

  • Sunnybrook Health Sciences Centre

    Toronto,
    Canada

    Active - Recruiting

  • Ciusss McQ - Chaur

    Trois-Rivières,
    Canada

    Active - Recruiting

  • St Paul's Hospital

    Vancouver,
    Canada

    Active - Recruiting

  • Vancouver General Hospital

    Vancouver,
    Canada

    Active - Recruiting

  • St. Boniface Hospital

    Winnipeg,
    Canada

    Active - Recruiting

  • St. Anne's University Hospital

    Brno,
    Czechia

    Active - Recruiting

  • Aalborg University Hospital

    Aalborg,
    Denmark

    Active - Recruiting

  • Aarhus University Hospital

    Aarhus,
    Denmark

    Active - Recruiting

  • Rigshospitalet - Copenhagen University Hospital

    Copenhagen,
    Denmark

    Active - Recruiting

  • Helsinki University Hospital

    Helsinki,
    Finland

    Active - Recruiting

  • TAYS Sydankeskus Oy

    Tampere,
    Finland

    Active - Recruiting

  • Turku University Hospital

    Turku,
    Finland

    Active - Recruiting

  • St. Vinzenz-Hospital

    Cologne,
    Germany

    Active - Recruiting

  • Helios Amper-Klinikum

    Dachau,
    Germany

    Active - Recruiting

  • Universitatsklinikum Frankfurt

    Frankfurt,
    Germany

    Active - Recruiting

  • Marienkrankenhaus

    Hamburg,
    Germany

    Active - Recruiting

  • Schoen Klink Hamburg

    Hamburg,
    Germany

    Active - Recruiting

  • University Heart & Vascular Center Hamburg

    Hamburg,
    Germany

    Active - Recruiting

  • WKK Heide

    Heide,
    Germany

    Active - Recruiting

  • Gottsegen National Cardiovascular Center

    Budapest,
    Hungary

    Active - Recruiting

  • University of Szeged

    Szeged,
    Hungary

    Active - Recruiting

  • Lisie Hospital

    Ernakulam, Kerala
    India

    Active - Recruiting

  • Meditrina Hospital

    Kollam, Kerala
    India

    Active - Recruiting

  • Caritas Hospital Trust

    Kottayam, Kerala
    India

    Active - Recruiting

  • Apollo Rajshree Hospitals

    Indore, Madhya Pradesh
    India

    Active - Recruiting

  • Rukmani Birla Hospital

    Jaipur, Rajasthan
    India

    Active - Recruiting

  • Apollo Hospital

    Chennai, Tamil Nadu
    India

    Active - Recruiting

  • The Madras Medical Mission

    Chennai, Tamil Nadu
    India

    Active - Recruiting

  • Meenakshi Mission Hospital and Research Center

    Madurai, Tamil Nadu
    India

    Active - Recruiting

  • Medicover Hospitals

    Hyderabad,
    India

    Active - Recruiting

  • Krishna Institute of Medical Sciences

    Secunderabad,
    India

    Active - Recruiting

  • Azienda USL Toscana Sud Est

    Arezzo,
    Italy

    Active - Recruiting

  • UOC Cardiologia - Ospedale Maggiore

    Bologna,
    Italy

    Active - Recruiting

  • Azienda Ospedaliero - Universitaria di Ferrara

    Ferrara,
    Italy

    Active - Recruiting

  • Misericordia Hospital

    Grosseto,
    Italy

    Active - Recruiting

  • Azienda USL-IRCCS di Reggio Emilia, Reggio

    Reggio Emilia,
    Italy

    Active - Recruiting

  • Sant Andrea Hospital - Sapienza University

    Rome,
    Italy

    Active - Recruiting

  • Sorlandet Hospital Arendal

    Kristiansand, Arendal
    Norway

    Active - Recruiting

  • Oslo University Hospital Ulleval

    Oslo,
    Norway

    Active - Recruiting

  • Stavanger University Hospital

    Stavanger,
    Norway

    Active - Recruiting

  • University Hospital Tromso

    Tromso,
    Norway

    Active - Recruiting

  • Provincial Specialized Hospital

    Legnica, Dolnoslaskie
    Poland

    Active - Recruiting

  • Miedziowym Centrum Zdrowia S.A. w Lubinie

    Lubin, Dolnoslaskie
    Poland

    Active - Recruiting

  • Medical University of Warsaw

    Warsaw, Mazowieckie
    Poland

    Active - Recruiting

  • Institute for Cardiovascular Diseases Dedinje

    Belgrade,
    Serbia

    Active - Recruiting

  • University Clinical Center of Serbia

    Belgrade,
    Serbia

    Active - Recruiting

  • Hospital Clinico San Carlos

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Ramon y Cajal

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario de La Princesa

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Virgen del Rocio

    Seville,
    Spain

    Active - Recruiting

  • Hospital Universitari i Politecnic La Fe

    Valencia,
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario de Valladolid

    Valladolid,
    Spain

    Active - Recruiting

  • Karolinska University Hospital

    Huddinge,
    Sweden

    Active - Recruiting

  • Lanssjukhuset RYHOV

    Jonkoping,,
    Sweden

    Active - Recruiting

  • Karlstad Central Hospital

    Karlstad,
    Sweden

    Active - Recruiting

  • Skane University Hospital

    Lund,
    Sweden

    Active - Recruiting

  • Danderyd Hospital

    Stockholm,
    Sweden

    Active - Recruiting

  • Umeå University Hospital

    Umeå,
    Sweden

    Active - Recruiting

  • Uppsala University Hospital

    Uppsala,
    Sweden

    Active - Recruiting

  • East Kent Hospitals University NHS Foundation Trust

    Ashford,
    United Kingdom

    Active - Recruiting

  • Blackpool Teaching Hospitals

    Blackpool,
    United Kingdom

    Active - Recruiting

  • Ninewells Hospital

    Dundee,
    United Kingdom

    Active - Recruiting

  • Harefield Hospital

    Harefield,
    United Kingdom

    Active - Recruiting

  • Kettering General Hospital

    Kettering,
    United Kingdom

    Active - Recruiting

  • University Hospitals of Leicester

    Leicester,
    United Kingdom

    Active - Recruiting

  • Liverpool Heart and Chest Hospital

    Liverpool,
    United Kingdom

    Active - Recruiting

  • Barts Health NHS Trust

    London,
    United Kingdom

    Active - Recruiting

  • Imperial College Healthcare NHS Trust

    London,
    United Kingdom

    Active - Recruiting

  • Royal Free London NHS Foundation Trust

    London,
    United Kingdom

    Active - Recruiting

  • Manchester University NHS Foundation Trust

    Manchester,
    United Kingdom

    Active - Recruiting

  • The James Cook University Hospital

    Middlesbrough,
    United Kingdom

    Active - Recruiting

  • Freeman Hospital

    Newcastle upon Tyne,
    United Kingdom

    Active - Recruiting

  • Royal Berkshire Foundation NHS Trust

    Reading,
    United Kingdom

    Active - Recruiting

  • Sheffield Teaching Hospitals

    Sheffield,
    United Kingdom

    Active - Recruiting

  • East and North Hertfordshire NHS Trust

    Stevenage,
    United Kingdom

    Active - Recruiting

  • Royal Cornwall Hospitals NHS Trust

    Truro,
    United Kingdom

    Active - Recruiting

  • The Royal Wolverhampton NHS Trust

    Wolverhampton,
    United Kingdom

    Active - Recruiting

  • Worcestershire Acute Hospitals NHS Trust

    Worcester,
    United Kingdom

    Active - Recruiting

  • UCLA

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • University of California, San Francisco

    San Francisco, California 94143
    United States

    Active - Recruiting

  • Cardiovascular Research Institute of Kansas

    Wichita, Kansas 67226
    United States

    Active - Recruiting

  • The Johns Hopkins University School of Medicine

    Baltimore, Maryland 21205
    United States

    Active - Recruiting

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

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

    Coon Rapids, Minnesota 55433
    United States

    Active - Recruiting

  • RWJ Barnabas Health

    Jersey City, New Jersey 07302
    United States

    Active - Recruiting

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Active - Recruiting

  • Bassett Medical Center

    Cooperstown, New York 13326
    United States

    Active - Recruiting

  • NYU Grossman School of Medicine

    New York, New York 10016
    United States

    Active - Recruiting

  • VA New York Harbor HealthCare System

    New York, New York 10010
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • University of Virginia Medical Center

    Charlottesville, Virginia 22903
    United States

    Active - Recruiting

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