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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05701358




Registration number
NCT05701358
Ethics application status
Date submitted
17/01/2023
Date registered
27/01/2023
Date last updated
19/06/2025

Titles & IDs
Public title
Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease
Scientific 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
Secondary ID [1] 0 0
COMPLETE-2
Universal Trial Number (UTN)
Trial acronym
COMPLETE-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myocardial Infarction 0 0
Coronary Artery Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Physiology-guided NCL PCI
Treatment: Surgery - Angiography-guided NCL PCI

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.

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.


Treatment: Surgery: 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.

Treatment: Surgery: Angiography-guided NCL PCI
PCI will be performed as per local practice
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Efficacy: Time to first occurrence of the composite of CV death, new MI, or IDR
Timepoint [1] 0 0
at study completion, a minimum of 2 years
Primary outcome [2] 0 0
Safety: Time to first occurrence of the composite of clinically significant bleeding, stroke, stent thrombosis, or contrast-associated acute kidney injury.
Timepoint [2] 0 0
at study completion, a minimum of 2 years
Secondary outcome [1] 0 0
Time to first occurrence of the composite of CV death or new MI.
Timepoint [1] 0 0
at study completion, a minimum of 2 years
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
at study completion, a minimum of 2 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2028
Actual
Sample size
Target
5100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
- Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Kansas
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
New Jersey
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Virginia
Country [10] 0 0
Austria
State/province [10] 0 0
Vienna
Country [11] 0 0
Canada
State/province [11] 0 0
Quebec
Country [12] 0 0
Canada
State/province [12] 0 0
Brampton
Country [13] 0 0
Canada
State/province [13] 0 0
Edmonton
Country [14] 0 0
Canada
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Hamilton
Country [15] 0 0
Canada
State/province [15] 0 0
Kingston
Country [16] 0 0
Canada
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Kitchener
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Canada
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London
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Canada
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Montréal
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Canada
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Newmarket
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Canada
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Nova Scotia
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Canada
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Ottawa
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Canada
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Québec
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Canada
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Regina
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Canada
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Saskatoon
Country [25] 0 0
Canada
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St. Catharines
Country [26] 0 0
Canada
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St. John's
Country [27] 0 0
Canada
State/province [27] 0 0
Thunder Bay
Country [28] 0 0
Canada
State/province [28] 0 0
Toronto
Country [29] 0 0
Canada
State/province [29] 0 0
Trois-Rivières
Country [30] 0 0
Canada
State/province [30] 0 0
Vancouver
Country [31] 0 0
Canada
State/province [31] 0 0
Winnipeg
Country [32] 0 0
Czechia
State/province [32] 0 0
Brno
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Denmark
State/province [33] 0 0
Aalborg
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Denmark
State/province [34] 0 0
Aarhus
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Denmark
State/province [35] 0 0
Copenhagen
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Finland
State/province [36] 0 0
Helsinki
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Finland
State/province [37] 0 0
Tampere
Country [38] 0 0
Finland
State/province [38] 0 0
Turku
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Germany
State/province [39] 0 0
Cologne
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Germany
State/province [40] 0 0
Dachau
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Germany
State/province [41] 0 0
Frankfurt
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Germany
State/province [42] 0 0
Hamburg
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Germany
State/province [43] 0 0
Heide
Country [44] 0 0
Hungary
State/province [44] 0 0
Budapest
Country [45] 0 0
Hungary
State/province [45] 0 0
Szeged
Country [46] 0 0
India
State/province [46] 0 0
Kerala
Country [47] 0 0
India
State/province [47] 0 0
Madhya Pradesh
Country [48] 0 0
India
State/province [48] 0 0
Rajasthan
Country [49] 0 0
India
State/province [49] 0 0
Tamil Nadu
Country [50] 0 0
India
State/province [50] 0 0
Hyderabad
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India
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Secunderabad
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Italy
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Arezzo
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Italy
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Bologna
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Italy
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Ferrara
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Italy
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Grosseto
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Italy
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Reggio Emilia
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Italy
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Rome
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Norway
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Arendal
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Norway
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Oslo
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Norway
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Stavanger
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Norway
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Tromso
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Poland
State/province [62] 0 0
Dolnoslaskie
Country [63] 0 0
Poland
State/province [63] 0 0
Mazowieckie
Country [64] 0 0
Serbia
State/province [64] 0 0
Belgrade
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Spain
State/province [65] 0 0
Madrid
Country [66] 0 0
Spain
State/province [66] 0 0
Seville
Country [67] 0 0
Spain
State/province [67] 0 0
Valencia
Country [68] 0 0
Spain
State/province [68] 0 0
Valladolid
Country [69] 0 0
Sweden
State/province [69] 0 0
Huddinge
Country [70] 0 0
Sweden
State/province [70] 0 0
Jonkoping,
Country [71] 0 0
Sweden
State/province [71] 0 0
Karlstad
Country [72] 0 0
Sweden
State/province [72] 0 0
Lund
Country [73] 0 0
Sweden
State/province [73] 0 0
Stockholm
Country [74] 0 0
Sweden
State/province [74] 0 0
Umeå
Country [75] 0 0
Sweden
State/province [75] 0 0
Uppsala
Country [76] 0 0
United Kingdom
State/province [76] 0 0
Ashford
Country [77] 0 0
United Kingdom
State/province [77] 0 0
Blackpool
Country [78] 0 0
United Kingdom
State/province [78] 0 0
Dundee
Country [79] 0 0
United Kingdom
State/province [79] 0 0
Harefield
Country [80] 0 0
United Kingdom
State/province [80] 0 0
Kettering
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Leicester
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Liverpool
Country [83] 0 0
United Kingdom
State/province [83] 0 0
London
Country [84] 0 0
United Kingdom
State/province [84] 0 0
Manchester
Country [85] 0 0
United Kingdom
State/province [85] 0 0
Middlesbrough
Country [86] 0 0
United Kingdom
State/province [86] 0 0
Newcastle upon Tyne
Country [87] 0 0
United Kingdom
State/province [87] 0 0
Reading
Country [88] 0 0
United Kingdom
State/province [88] 0 0
Sheffield
Country [89] 0 0
United Kingdom
State/province [89] 0 0
Stevenage
Country [90] 0 0
United Kingdom
State/province [90] 0 0
Truro
Country [91] 0 0
United Kingdom
State/province [91] 0 0
Wolverhampton
Country [92] 0 0
United Kingdom
State/province [92] 0 0
Worcester

Funding & Sponsors
Primary sponsor type
Other
Name
Population Health Research Institute
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Shamir Mehta, MD
Address 0 0
Population Health Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
COMPLETE-2 Project Office
Address 0 0
Country 0 0
Phone 0 0
(905) 521-2100
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05701358