NCT05701358ClinicalTrials.gov

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

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

RecruitingTaking participants now, according to the registry record.

Contact this study

In brief

Interventional5,100 participants sought113 sites17 countries

Registered in 1 registry

ClinicalTrials.govNCT05701358Open this record at ClinicalTrials.govSynced 2 months ago

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Trial information is shown as published by the registry, in its original language.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2023-01-27; recorded start 2023-06-22
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Present: Uses blinding (masking)A masking level is recorded in the record
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 34 other studies in this databaseCounted from the lead sponsor named in the record (Population Health Research Institute)
Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database

The record lists 2 conditions.
Lead sponsor type recorded as: other.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourDEFINITIVE

A definitive-grade design for a study of this type, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding7/20
Single-blind
Control arm15/15
Active-comparator control arm
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type10/10
Mortality / MACE endpoint (hard clinical outcome)
Multi-centre8/8
Multi-centre: 113 sites
Data monitoring committee7/7
A data monitoring committee is in place
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleLARGE

A large study, international in scope: 5,100 participants (target), run at 113 sites, across 17 countries.

How this score is built

Enrolment36/40
5,100 participants (target)
Site count23/25
113 sites
Country count15/15
17 countries
Planned duration10/10
Planned over about 60 months
Sponsor scale5/10
Population Health Research Institute has led 36 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

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.

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.

Conditions

Acute Myocardial Infarction
Coronary Artery Disease

Eligibility

Eligibility
Sex	All
Ages	18 Years – No maximum
Healthy volunteers	No

Eligibility as written in the registry

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

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study design
Study type	Interventional
Phase	Not applicable
Allocation	Randomised
Intervention model	PARALLEL
Primary purpose	TREATMENT
Masking	SINGLE (1)
Enrolment	5,100 participants sought

Sponsor and collaborators

Population Health Research Institute Sponsor

Arms and interventions

Physiology-guided Non-Culprit-Lesion (NCL) PCIACTIVE_COMPARATOR
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.
Angiography-guided NCL PCIOTHER
Patients randomized to this group will undergo routine staged PCI of all qualifying NCLs that were identified prior to randomization.

Interventions

Procedure Angiography-guided NCL PCI
PCI will be performed as per local practice
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.

Outcome measures

Primary outcome
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
Primary outcome
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 outcome
Time to first occurrence of the composite of CV death or new MI.
Time frame at study completion, a minimum of 2 years
Secondary outcome
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

Dates

Dates
Start date	June 22, 2023 (actual)
Primary completion	June 1, 2028 (estimated)
Completion	June 1, 2028 (estimated)
First posted	January 27, 2023 (actual)
Last updated	June 19, 2025
Results posted	Not stated in the registry record
Status last verified	June 2025

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

113 sites are recruiting

Australia

Australia
Facility	City	State or region	Status
Westmead Hospital	Westmead	New South Wales	Recruiting

Austria

Austria
Facility	City	State or region	Status
Klinik Floridsdorf	Vienna		Recruiting

Canada

Canada
Facility	City	State or region	Status
William Osler Health System	Brampton		Recruiting
University of Alberta Hospital, Mazankowski Heart	Edmonton		Recruiting
Hamilton Health Sciences	Hamilton		Recruiting
Kingston Health Sciences Centre	Kingston		Recruiting
St. Mary's General Hospital	Kitchener		Recruiting
London Health Sciences Centre	London		Recruiting
McGill University Health Centre (MUHC)	Montreal	Quebec	Recruiting
Hopital du Sacre-Coeur de Montreal	Montreal		Recruiting
Centre Hospitalier de l'Universite de Montreal	Montreal		Recruiting
Southlake Regional Health Centre	Newmarket		Recruiting
Nova Scotia Health	Nova Scotia		Recruiting
University of Ottawa Heart Institute	Ottawa		Recruiting
Institut Universitaire de Cardiologie et de Pneumologie de Québec	Québec		Recruiting
Regina General Hospital	Regina		Recruiting
Royal University Hospital	Saskatoon		Recruiting
Niagara Health	St. Catharines		Recruiting
Newfoundland and Labrador Health Services	St. John's		Recruiting
Thunder Bay Regional Health Sciences Centre	Thunder Bay		Recruiting
Sunnybrook Health Sciences Centre	Toronto		Recruiting
St. Michael's Hospital (Unity Health Toronto)	Toronto		Recruiting
Ciusss McQ - Chaur	Trois-Rivières		Recruiting
St Paul's Hospital	Vancouver		Recruiting
Vancouver General Hospital	Vancouver		Recruiting
St. Boniface Hospital	Winnipeg		Recruiting

Czechia

Czechia
Facility	City	State or region	Status
St. Anne's University Hospital	Brno		Recruiting

Denmark

Denmark
Facility	City	Status
Aalborg University Hospital	Aalborg	Recruiting
Aarhus University Hospital	Aarhus	Recruiting
Rigshospitalet - Copenhagen University Hospital	Copenhagen	Recruiting

Finland

Finland
Facility	City	Status
Helsinki University Hospital	Helsinki	Recruiting
TAYS Sydankeskus Oy	Tampere	Recruiting
Turku University Hospital	Turku	Recruiting

Germany

Germany
Facility	City	Status
St. Vinzenz-Hospital	Cologne	Recruiting
Helios Amper-Klinikum	Dachau	Recruiting
Universitatsklinikum Frankfurt	Frankfurt	Recruiting
Marienkrankenhaus	Hamburg	Recruiting
Schoen Klink Hamburg	Hamburg	Recruiting
University Heart & Vascular Center Hamburg	Hamburg	Recruiting
WKK Heide	Heide	Recruiting

Hungary

Hungary
Facility	City	State or region	Status
Gottsegen National Cardiovascular Center	Budapest		Recruiting
University of Szeged	Szeged		Recruiting

India

India
Facility	City	State or region	Status
The Madras Medical Mission	Chennai	Tamil Nadu	Recruiting
Apollo Hospital	Chennai	Tamil Nadu	Recruiting
Lisie Hospital	Ernākulam	Kerala	Recruiting
Medicover Hospitals	Hyderabad		Recruiting
Apollo Rajshree Hospitals	Indore	Madhya Pradesh	Recruiting
Rukmani Birla Hospital	Jaipur	Rajasthan	Recruiting
Meditrina Hospital	Kollam	Kerala	Recruiting
Caritas Hospital Trust	Kottayam	Kerala	Recruiting

63 further sites are listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

No changes have been recorded since we first ingested this record.

A change is recorded each time the sponsor updates the registry record. Status, dates, enrolment and sites appear here as they move.

Registry: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT05701358

Categories

Registered in 1 registry

Interested in this study?

How this study is set up

Summary

Conditions

Eligibility

Eligibility as written in the registry

Eligibility in plain statements

Study design

Sponsor and collaborators

Arms and interventions

Interventions

Outcome measures

Dates

Locations

Australia

Austria

Canada

Czechia

Denmark

Finland

Germany

Hungary

India

Study documents

Changes over time