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Acute Myocardial InfarctionCOMPLETE-2NCT05701358

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

A study testing Physiology-guided NCL PCI and Angiography-guided NCL PCI in people with Acute Myocardial Infarction and Coronary Artery Disease, run by Population Health Research Institute at 138 sites in 20 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Physiology-guided NCL PCI and Angiography-guided NCL PCI
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,100 participants
Where
138 sitesin 20 countries
Study dates
22 Jun 2023to Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients presenting with STEMI or type 1 NSTEMI and within 72 hours of successful culprit-lesion PCI
  • Residual coronary artery disease defined as at least 1 additional non-infarct-related coronary artery stenosis that meets all of the following criteria:
  • Amenable to successful treatment with PCI
  • At least 50% diameter stenosis by visual estimation
  • At least 2.5 mm in diameter
  • Planned complete revascularization strategy for qualifying MI

Who cannot join

  • Planned or prior coronary artery bypass graft (CABG) surgery
  • 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
  • Prior PCI of a non-culprit lesion in a different vessel from the culprit lesion within 45 days of randomization
  • Planned medical treatment of all qualifying non-culprit lesions (i.e., no PCI)
  • Presence of severe non-culprit-lesion stenosis with reduced epicardial flow (TIMI flow ≤ 2) or >90% visual diameter stenosis
  • 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)
Show all 10Show fewer
  • The only qualifying non-culprit lesion is in the same vessel territory as the culprit lesion
  • 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
  • Non-cardiovascular co-morbidity with expected life expectancy <2 years
  • Any other medical, geographic, or social factor making study participation impractical or precluding 5 year follow-up

Trial locations and contacts

138 sites in 20 countries.

138 sites in 20 countries

Canada24 sites

  • William Osler Health System

    Brampton

  • University of Alberta Hospital, Mazankowski Heart

    Edmonton

  • Hamilton Health Sciences

    Hamilton

  • Kingston Health Sciences Centre

    Kingston

  • St. Mary's General Hospital

    Kitchener

  • London Health Sciences Centre

    London

  • McGill University Health Centre (MUHC)

    Montreal, Quebec, H4A 3J1

  • Centre Hospitalier de l'Universite de Montreal

    Montreal

  • Hopital du Sacre-Coeur de Montreal

    Montreal

  • Southlake Regional Health Centre

    Newmarket

  • Nova Scotia Health

    Nova Scotia

  • University of Ottawa Heart Institute

    Ottawa

  • Institut Universitaire de Cardiologie et de Pneumologie de Québec

    Québec

  • Regina General Hospital

    Regina

  • Royal University Hospital

    Saskatoon

  • Niagara Health

    St. Catharines

  • Newfoundland and Labrador Health Services

    St. John's

  • Thunder Bay Regional Health Sciences Centre

    Thunder Bay

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

    Toronto

  • Sunnybrook Health Sciences Centre

    Toronto

  • Ciusss McQ - Chaur

    Trois-Rivières

  • St Paul's Hospital

    Vancouver

  • Vancouver General Hospital

    Vancouver

  • St. Boniface Hospital

    Winnipeg

Other trials in Canada

United Kingdom21 sites

  • East Kent Hospitals University NHS Foundation Trust

    Ashford

  • Blackpool Teaching Hospitals

    Blackpool

  • Ninewells Hospital

    Dundee

  • Harefield Hospital

    Harefield

  • Kettering General Hospital

    Kettering

  • Leeds General Infirmary

    Leeds

  • University Hospitals of Leicester

    Leicester

  • Liverpool Heart and Chest Hospital

    Liverpool

  • Barts Health NHS Trust

    London

  • Imperial College Healthcare NHS Trust

    London

  • Royal Free London NHS Foundation Trust

    London

  • Western Health and Social Care Trust

    Londonderry

  • Manchester University NHS Foundation Trust

    Manchester

  • The James Cook University Hospital

    Middlesbrough

  • Freeman Hospital

    Newcastle upon Tyne

  • Royal Berkshire Foundation NHS Trust

    Reading

  • Sheffield Teaching Hospitals

    Sheffield

  • East and North Hertfordshire NHS Trust

    Stevenage

  • Royal Cornwall Hospitals NHS Trust

    Truro

  • The Royal Wolverhampton NHS Trust

    Wolverhampton

  • Worcestershire Acute Hospitals NHS Trust

    Worcester

Other trials in United Kingdom

United States14 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • The Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21205

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22903

  • Cleveland Clinic

    Cleveland, Ohio, 44195

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

    Coon Rapids, Minnesota, 55433

  • Bassett Medical Center

    Cooperstown, New York, 13326

  • RWJ Barnabas Health

    Jersey City, New Jersey, 07302

  • UCLA

    Los Angeles, California, 90095

  • VA New York Harbor HealthCare System

    New York, New York, 10010

  • NYU Grossman School of Medicine

    New York, New York, 10016

  • The Heart Hospital Baylor Plano

    Plano, Texas, 75093

  • University of California, San Francisco

    San Francisco, California, 94143

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Cardiovascular Research Institute of Kansas

    Wichita, Kansas, 67226

Other trials in United States

India10 sites

  • Apollo Hospital

    Chennai, Tamil Nadu

  • The Madras Medical Mission

    Chennai, Tamil Nadu

  • Lisie Hospital

    Ernākulam, Kerala

  • Medanta - The Medicity

    Gurugramam

  • Apollo Rajshree Hospitals

    Indore, Madhya Pradesh

  • Rukmani Birla Hospital

    Jaipur, Rajasthan

  • Meditrina Hospital

    Kollam, Kerala

  • Caritas Hospital Trust

    Kottayam, Kerala

  • Meenakshi Mission Hospital and Research Center

    Madurai, Tamil Nadu

  • Krishna Institute of Medical Sciences

    Secunderabad

Other trials in India

Australia9 sites

  • Flinders Medical Centre

    Bedford Park

  • Eastern Health

    Box Hill

  • Campbelltown Hospital

    Campbelltown

  • The Prince Charles Hospital

    Chermside

  • Gosford Hospital

    Gosford

  • Northern Health

    Melbourne

  • Royal Melbourne Hospital

    Parkville

  • Royal Perth Hospital

    Perth

  • Westmead Hospital

    Westmead, New South Wales

Other trials in Australia

Germany9 sites

  • Kerckhoff-Klinik Bad Nauheim

    Bad Nauheim

  • Berufsgenossenschaftliches Universitatsklinikum

    Bochum

  • St. Vinzenz-Hospital

    Cologne

  • Helios Amper-Klinikum

    Dachau

  • Universitatsklinikum Frankfurt

    Frankfurt

  • Schoen Klink Hamburg

    Hamburg

  • University Heart & Vascular Center Hamburg

    Hamburg

  • WKK Heide

    Heide

  • Heart Center Leipzig

    Leipzig

Other trials in Germany

Italy8 sites

  • Azienda USL Toscana Sud Est

    Arezzo

  • UOC Cardiologia - Ospedale Maggiore

    Bologna

  • Azienda Ospedaliero - Universitaria di Ferrara

    Ferrara

  • Misericordia Hospital

    Grosseto

  • Fondazione IRCCS Policlinico San Matteo

    Pavia

  • Azienda USL-IRCCS di Reggio Emilia, Reggio

    Reggio Emilia

  • Sant Andrea Hospital - Sapienza University

    Rome

  • AOU Citta Della Salute e della Scienza di Torino

    Torino

Other trials in Italy

Sweden8 sites

  • Sahlgrenska University Hospital

    Gothenburg

  • Karolinska University Hospital

    Huddinge

  • Lanssjukhuset RYHOV

    Jönköping

  • Karlstad Central Hospital

    Karlstad

  • Skane University Hospital

    Lund

  • Danderyd Hospital

    Stockholm

  • Umeå University Hospital

    Umeå

  • Uppsala University Hospital

    Uppsala

Other trials in Sweden

Spain7 sites

  • Hospital Clinico San Carlos

    Madrid

  • Hospital Ramon y Cajal

    Madrid

  • Hospital Universitario de La Princesa

    Madrid

  • Hospital Universitario La Paz

    Madrid

  • Hospital Virgen del Rocio

    Seville

  • Hospital Universitari i Politecnic La Fe

    Valencia

  • Hospital Clinico Universitario de Valladolid

    Valladolid

Other trials in Spain

Poland5 sites

  • Provincial Specialized Hospital

    Legnica, Lower Silesian Voivodeship

  • Miedziowym Centrum Zdrowia S.A. w Lubinie

    Lubin, Lower Silesian Voivodeship

  • Medical University of Warsaw

    Warsaw, Masovian Voivodeship

  • Provincial Specialist Hospital in Wroclaw

    Wroclaw

  • Tadeusz Marciniak Lower Silesia Specialist Hospital

    Wroclaw

Other trials in Poland

Hungary4 sites

  • Gottsegen National Cardiovascular Center

    Budapest

  • Semmelweis University Heart and Vascular Center

    Budapest

  • Szabolcs-Szatmar-Bereg County Hospitals and University

    Nyíregyháza

  • University of Szeged

    Szeged

Other trials in Hungary

Netherlands4 sites

  • OLVG

    Amsterdam

  • Albert Schweitzer Ziekenhuis

    Dordrecht

  • Zuyderland Medisch Centrum

    Heerlen

  • Radboud University Medical Cente

    Nijmegen

Other trials in Netherlands

Denmark3 sites

  • Aalborg University Hospital

    Aalborg

  • Aarhus University Hospital

    Aarhus

  • Rigshospitalet - Copenhagen University Hospital

    Copenhagen

Other trials in Denmark

Finland3 sites

  • Helsinki University Hospital

    Helsinki

  • TAYS Sydankeskus Oy

    Tampere

  • Turku University Hospital

    Turku

Other trials in Finland

Norway3 sites

  • Sorlandet Hospital Arendal

    Kristiansand, Arendal

  • Oslo University Hospital Ulleval

    Oslo

  • Stavanger University Hospital

    Stavanger

Other trials in Norway

Serbia2 sites

  • Institute for Cardiovascular Diseases Dedinje

    Belgrade

  • University Clinical Center of Serbia

    Belgrade

Other trials in Serbia

Austria1 site

  • Klinik Floridsdorf

    Vienna

Other trials in Austria

Greece1 site

  • General University Hospital of Patras

    Rio

Other trials in Greece

Ireland1 site

  • University Hospital Galway

    Galway

Other trials in Ireland

South Africa1 site

  • Groote Schuur Hospital

    Cape Town

Other trials in South Africa

About this study

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

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.

Read the 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.
Being tested
Physiology-guided NCL PCI, Angiography-guided NCL PCI
Keywords
NSTEMI, STEMI, multi-vessel disease, optical coherence tomography, FFR, RFR, percutaneous coronary intervention
Medical subject headings
Coronary Artery Disease, Non-ST Elevated Myocardial Infarction, ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physiology-guided NCL PCIProcedure or surgery

    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 PCIProcedure or surgery

    PCI will be performed as per local practice

Study groups in NCT05701358
Study groupRoleWhat they receive
Physiology-guided Non-Culprit-Lesion (NCL) PCIActive comparatorPatients 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.
Receives: Procedure: Physiology-guided NCL PCI
Angiography-guided NCL PCIOtherPatients randomized to this group will undergo routine staged PCI of all qualifying NCLs that were identified prior to randomization.
Receives: Procedure: Angiography-guided NCL PCI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy: Time to first occurrence of the composite of CV death, new MI, or IDR

    Measured: at study completion, a minimum of 2 years

  2. Safety: Time to first occurrence of the composite of clinically significant bleeding, stroke, stent thrombosis, or contrast-associated acute kidney injury.

    Measured: at study completion, a minimum of 2 years

Secondary outcomes (2)

  1. Time to first occurrence of the composite of CV death or new MI.

    Measured: at study completion, a minimum of 2 years

  2. Net clinical outcome: Time to first occurrence of the composite of CV death, new MI, clinically significant bleeding, stroke, stent thrombosis or contrast-associated acute kidney injury.

    Measured: at study completion, a minimum of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2023
  2. Study start22 Jun 2023
  3. Primary completionJun 2028 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
5,100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05701358
Sponsor's protocol ID
COMPLETE-2
Acronym
COMPLETE-2
Status last verified
Oct 2026
First submitted
17 Jan 2023
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Heller T, Ong P, Sechtem U, Bekeredjian R. Management of multivessel disease in patients with ST-segment elevation myocardial infarction: questioning routine immediate complete revascularization in all patients. Coron Artery Dis. 2026 Dec 1;37(8):625-633. doi: 10.1097/MCA.0000000000001661. Epub 2026 Jul 10.

    PubMed 42423587

Questions about this trial

What is this clinical trial studying?

A study testing Physiology-guided NCL PCI and Angiography-guided NCL PCI in people with Acute Myocardial Infarction and Coronary Artery Disease, run by Population Health Research Institute at 138 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 138 sites in Canada, United Kingdom, United States, India, Australia and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05701358, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

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