Comparing Physiology-guided NCL PCI with Angiography-guided NCL PCI for acute myocardial infarction
Official title: 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
Interventions
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.
Angiography-guided NCL PCI
PCI will be performed as per local practice
Canadian Sites (24)
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
McGill University Health Centre (MUHC)
Montreal, Quebec, Canada
Eligibility Criteria
See who this study is looking for16 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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
Exclusion
- −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 randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →
- −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)
- −The only qualifying non-culprit lesion is in the same vessel territory as the culprit lesion
- −BaselineBaselineYour starting measurements, taken before treatment begins.Read more → 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-upFollow-upContinued check-ins after the treatment part is finished.Read more →
- −Planned or prior coronary artery bypass graft (CABG) surgery
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
What is being given or done in this study: Physiology-guided NCL PCI, Angiography-guided NCL PCI.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
One group of people involved — usually the participants — is not told which treatment is which.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 5,100 people.
The study is currently expected to finish around June 2028.
The main measurement is taken over: at study completion, a minimum of 2 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Efficacy: Time to first occurrence of the composite of CV death, new MI, or IDR — measured over at study completion, a minimum of 2 years.
Safety: Time to first occurrence of the composite of clinically significant bleeding, stroke, stent thrombosis, or contrast-associated acute kidney injury — measured over at study completion, a minimum of 2 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05701358 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Physiology-guided NCL PCIProcedure
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.
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
About Angiography-guided NCL PCIProcedure
PCI will be performed as per local practice
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
One group of people involved — usually the participants — is not told which treatment is which.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: at study completion, a minimum of 2 years.
The study as a whole is currently expected to finish around 2028-06.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 5,100 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 26 locations, including: Brampton, Canada; Edmonton, Canada; Hamilton, Canada; Kingston, Canada; Kitchener, Canada; London, Canada, and 20 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (6)
University of Michigan
Ann Arbor, Michigan, United States
Metropolitan Cardiology Consultants / Metropolitan Heart and Vascular Institute (MCC/MHVI)
Coon Rapids, Minnesota, United States
Bassett Medical Center
Cooperstown, New York, United States
VA New York Harbor HealthCare System
New York, New York, United States
NYU Grossman School of Medicine
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.