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

RekrutiertNimmt laut Registereintrag derzeit Teilnehmende auf.

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Kurz gefasst

Interventionell5.100 Teilnehmende gesucht113 Studienzentren17 Länder

Kategorien

Herz-Kreislauf100%

In 1 Register registriert

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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.

Zusammenfassung

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.

Erkrankungen

Acute Myocardial Infarction
Coronary Artery Disease

Eignung

Eignung
Geschlecht	Alle
Alter	18 Years – Kein Höchstalter
Gesunde Freiwillige	Nein

Eignung im Wortlaut des Registers

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

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

Studiendesign
Studientyp	Interventionell
Phase	Nicht zutreffend
Zuteilung	Randomisiert
Interventionsmodell	PARALLEL
Primäres Ziel	TREATMENT
Verblindung	SINGLE (1)
Teilnahme	5.100 Teilnehmende gesucht

Sponsor und Mitwirkende

Population Health Research Institute Sponsor

Studienarme und Interventionen

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.

Interventionen

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

Endpunkte

Primärer Endpunkt
Efficacy: Time to first occurrence of the composite of CV death, new MI, or IDR
Zeitrahmen at study completion, a minimum of 2 years
Primärer Endpunkt
Safety: Time to first occurrence of the composite of clinically significant bleeding, stroke, stent thrombosis, or contrast-associated acute kidney injury.
Zeitrahmen at study completion, a minimum of 2 years
Sekundärer Endpunkt
Time to first occurrence of the composite of CV death or new MI.
Zeitrahmen at study completion, a minimum of 2 years
Sekundärer Endpunkt
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.
Zeitrahmen at study completion, a minimum of 2 years

Daten

Daten
Startdatum	22. Juni 2023 (tatsächlich)
Primärer Abschluss	1. Juni 2028 (geschätzt)
Abschluss	1. Juni 2028 (geschätzt)
Erstveröffentlichung	27. Januar 2023 (tatsächlich)
Zuletzt aktualisiert	19. Juni 2025
Ergebnisse veröffentlicht	Im Registereintrag nicht angegeben
Status zuletzt bestätigt	Juni 2025

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

113 Studienzentren rekrutieren

Australia

Australia
Einrichtung	Stadt	Bundesland oder Region	Status
Westmead Hospital	Westmead	New South Wales	Rekrutiert

Austria

Austria
Einrichtung	Stadt	Bundesland oder Region	Status
Klinik Floridsdorf	Vienna		Rekrutiert

Canada

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

Czechia

Czechia
Einrichtung	Stadt	Bundesland oder Region	Status
St. Anne's University Hospital	Brno		Rekrutiert

Denmark

Denmark
Einrichtung	Stadt	Status
Aalborg University Hospital	Aalborg	Rekrutiert
Aarhus University Hospital	Aarhus	Rekrutiert
Rigshospitalet - Copenhagen University Hospital	Copenhagen	Rekrutiert

Finland

Finland
Einrichtung	Stadt	Status
Helsinki University Hospital	Helsinki	Rekrutiert
TAYS Sydankeskus Oy	Tampere	Rekrutiert
Turku University Hospital	Turku	Rekrutiert

Germany

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

Hungary

Hungary
Einrichtung	Stadt	Bundesland oder Region	Status
Gottsegen National Cardiovascular Center	Budapest		Rekrutiert
University of Szeged	Szeged		Rekrutiert

India

India
Einrichtung	Stadt	Bundesland oder Region	Status
The Madras Medical Mission	Chennai	Tamil Nadu	Rekrutiert
Apollo Hospital	Chennai	Tamil Nadu	Rekrutiert
Lisie Hospital	Ernākulam	Kerala	Rekrutiert
Medicover Hospitals	Hyderabad		Rekrutiert
Apollo Rajshree Hospitals	Indore	Madhya Pradesh	Rekrutiert
Rukmani Birla Hospital	Jaipur	Rajasthan	Rekrutiert
Meditrina Hospital	Kollam	Kerala	Rekrutiert
Caritas Hospital Trust	Kottayam	Kerala	Rekrutiert

63 weitere Studienzentren sind im Registereintrag aufgeführt.

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

Seit wir diesen Eintrag erstmals eingelesen haben, wurden keine Änderungen erfasst.

Eine Änderung wird jedes Mal erfasst, wenn der Sponsor den Registereintrag aktualisiert. Status, Daten, Teilnahme und Studienzentren erscheinen hier, sobald sie sich ändern.

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