ClinicalTrials.gg
Active, not recruitingNCT05701358COMPLETE-2Updated Oct 20, 2026

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

An interventional study of Physiology-guided NCL PCI and Angiography-guided NCL PCI in Acute Myocardial Infarction and Coronary Artery Disease, sponsored by Population Health Research Institute. Active, not recruiting at 138 sites in 20 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by Population Health Research Institute · Not applicable, Interventional, and Treatment

Updated Oct 20, 2026Now Active, not recruitingFirst sites in 4 new countries+3 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
5,100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

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.
02

Conditions studied

  • Acute Myocardial Infarction
  • Coronary Artery Disease

Keywords

  • NSTEMI
  • STEMI
  • multi-vessel disease
  • optical coherence tomography
  • FFR
  • RFR
  • percutaneous coronary intervention
03

In context

Coronary Artery Disease

4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.

This study's planned enrollment of 5,100 is above the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Population Health Research Institute is the lead sponsor of 115 studies on the registry; 26 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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 \<2 years
  10. Any other medical, geographic, or social factor making study participation impractical or precluding 5 year follow-up
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
5,100 participants (estimated)

Study arms

  • Active comparator
    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.

    Procedure: Physiology-guided NCL PCI

  • Other
    Angiography-guided NCL PCI

    Patients randomized to this group will undergo routine staged PCI of all qualifying NCLs that were identified prior to randomization.

    Procedure: Angiography-guided NCL PCI

Interventions

  • ProcedurePhysiology-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.

  • ProcedureAngiography-guided NCL PCI

    PCI will be performed as per local practice

06

What researchers measure

Primary outcomes

  1. 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

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

    Time frame: at study completion, a minimum of 2 years

Secondary outcomes

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

    Time frame: 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.

    Time frame: at study completion, a minimum of 2 years

07

Study locations

138 sites

Showing the first 100 of 138 sites across 20 countries. Choose a country and city above to see the rest.

08

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Active, not recruiting
changed Oct 20, 2026
Sites
38 sites added, 13 sites removed — first sites in Greece, Ireland, Netherlands and South Africa; no longer in Czechia
Show 38 added (8 Australia, 5 Poland, 4 Netherlands, 3 Canada, 3 Germany, 2 United States, 2 Hungary, 2 India, 2 Italy, 2 Sweden, 2 United Kingdom, 1 Greece, 1 Ireland, 1 South Africa)
  • Montefiore Medical Center · The Bronx, United States
  • The Heart Hospital Baylor Plano · Plano, United States
  • Flinders Medical Centre · Bedford Park, Australia
  • Eastern Health · Box Hill, Australia
  • Campbelltown Hospital · Campbelltown, Australia
  • The Prince Charles Hospital · Chermside, Australia
  • Gosford Hospital · Gosford, Australia
  • Northern Health · Melbourne, Australia
  • Royal Melbourne Hospital · Parkville, Australia
  • Royal Perth Hospital · Perth, Australia
  • McGill University Health Centre (MUHC) · Montreal, Canada
  • Centre Hospitalier de l'Universite de Montreal · Montreal, Canada
  • Hopital du Sacre-Coeur de Montreal · Montreal, Canada
  • Kerckhoff-Klinik Bad Nauheim · Bad Nauheim, Germany
  • Berufsgenossenschaftliches Universitatsklinikum · Bochum, Germany
  • Heart Center Leipzig · Leipzig, Germany
  • General University Hospital of Patras · Rio, Greece
  • Semmelweis University Heart and Vascular Center · Budapest, Hungary
  • Szabolcs-Szatmar-Bereg County Hospitals and University · Nyíregyháza, Hungary
  • Lisie Hospital · Ernākulam, India
  • Medanta - The Medicity · Gurugramam, India
  • University Hospital Galway · Galway, Ireland
  • Fondazione IRCCS Policlinico San Matteo · Pavia, Italy
  • AOU Citta Della Salute e della Scienza di Torino · Torino, Italy
  • OLVG · Amsterdam, Netherlands
  • Albert Schweitzer Ziekenhuis · Dordrecht, Netherlands
  • Zuyderland Medisch Centrum · Heerlen, Netherlands
  • Radboud University Medical Cente · Nijmegen, Netherlands
  • Provincial Specialized Hospital · Legnica, Poland
  • Miedziowym Centrum Zdrowia S.A. w Lubinie · Lubin, Poland
  • …and 8 more on the registry record
Show 13 removed
  • Montefiore Medical Center · Bronx, United States
  • McGill University Health Centre (MUHC) · Montréal, Canada
  • Centre Hospitalier de l'Universite de Montreal · Montréal, Canada
  • Hopital du Sacre-Coeur de Montreal · Montréal, Canada
  • St. Anne's University Hospital · Brno, Czechia
  • Marienkrankenhaus · Hamburg, Germany
  • Lisie Hospital · Ernakulam, India
  • Medicover Hospitals · Hyderabad, India
  • University Hospital Tromso · Tromso, Norway
  • Provincial Specialized Hospital · Legnica, Poland
  • Miedziowym Centrum Zdrowia S.A. w Lubinie · Lubin, Poland
  • Medical University of Warsaw · Warsaw, Poland
  • Lanssjukhuset RYHOV · Jonkoping,, Sweden
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    Recruiting→Active, not recruiting
    38 sites added, 13 sites removed — first sites in Greece, Ireland, Netherlands and South Africa; no longer in Czechia
    Show 38 added (8 Australia, 5 Poland, 4 Netherlands, 3 Canada, 3 Germany, 2 United States, 2 Hungary, 2 India, 2 Italy, 2 Sweden, 2 United Kingdom, 1 Greece, 1 Ireland, 1 South Africa)
    • Montefiore Medical Center · The Bronx, United States
    • The Heart Hospital Baylor Plano · Plano, United States
    • Flinders Medical Centre · Bedford Park, Australia
    • Eastern Health · Box Hill, Australia
    • Campbelltown Hospital · Campbelltown, Australia
    • The Prince Charles Hospital · Chermside, Australia
    • Gosford Hospital · Gosford, Australia
    • Northern Health · Melbourne, Australia
    • Royal Melbourne Hospital · Parkville, Australia
    • Royal Perth Hospital · Perth, Australia
    • McGill University Health Centre (MUHC) · Montreal, Canada
    • Centre Hospitalier de l'Universite de Montreal · Montreal, Canada
    • Hopital du Sacre-Coeur de Montreal · Montreal, Canada
    • Kerckhoff-Klinik Bad Nauheim · Bad Nauheim, Germany
    • Berufsgenossenschaftliches Universitatsklinikum · Bochum, Germany
    • Heart Center Leipzig · Leipzig, Germany
    • General University Hospital of Patras · Rio, Greece
    • Semmelweis University Heart and Vascular Center · Budapest, Hungary
    • Szabolcs-Szatmar-Bereg County Hospitals and University · Nyíregyháza, Hungary
    • Lisie Hospital · Ernākulam, India
    • Medanta - The Medicity · Gurugramam, India
    • University Hospital Galway · Galway, Ireland
    • Fondazione IRCCS Policlinico San Matteo · Pavia, Italy
    • AOU Citta Della Salute e della Scienza di Torino · Torino, Italy
    • OLVG · Amsterdam, Netherlands
    • Albert Schweitzer Ziekenhuis · Dordrecht, Netherlands
    • Zuyderland Medisch Centrum · Heerlen, Netherlands
    • Radboud University Medical Cente · Nijmegen, Netherlands
    • Provincial Specialized Hospital · Legnica, Poland
    • Miedziowym Centrum Zdrowia S.A. w Lubinie · Lubin, Poland
    • …and 8 more on the registry record
    Show 13 removed
    • Montefiore Medical Center · Bronx, United States
    • McGill University Health Centre (MUHC) · Montréal, Canada
    • Centre Hospitalier de l'Universite de Montreal · Montréal, Canada
    • Hopital du Sacre-Coeur de Montreal · Montréal, Canada
    • St. Anne's University Hospital · Brno, Czechia
    • Marienkrankenhaus · Hamburg, Germany
    • Lisie Hospital · Ernakulam, India
    • Medicover Hospitals · Hyderabad, India
    • University Hospital Tromso · Tromso, Norway
    • Provincial Specialized Hospital · Legnica, Poland
    • Miedziowym Centrum Zdrowia S.A. w Lubinie · Lubin, Poland
    • Medical University of Warsaw · Warsaw, Poland
    • Lanssjukhuset RYHOV · Jonkoping,, Sweden
    + 5 other changes: verification date, oversight details, contact details, data sharing statement and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT05701358
Responsible party
Sponsor
First posted
Jan 27, 2023
Start date
Jun 22, 2023
Primary completion
Jun 2028 (estimated)
Completion
Jun 2028 (estimated)
Last update
Oct 20, 2026

Study contacts

Shamir Mehta, MD
principal investigator · Population Health Research Institute

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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