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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05333068




Registration number
NCT05333068
Ethics application status
Date submitted
11/04/2022
Date registered
18/04/2022

Titles & IDs
Public title
COMBINE-INTERVENE: COMBINEd Ischemia and Vulnerable Plaque Percutaneous INTERVENtion to Reduce Cardiovascular Events
Scientific title
COMBINEd Ischemia and Vulnerable Plaque Percutaneous INTERVENtion to Reduce Cardiovascular Events
Secondary ID [1] 0 0
9357
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multivessel Coronary Artery Disease 0 0
Ischemia 0 0
Vulnerable Plaque 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
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - PCI revascularization strategy based on combined FFR and OCT assessment
Treatment: Surgery - PCI revascularization strategy based FFR assessment

Experimental: MVD > 2 50% angiographic stenosis PCI revascularization strategy based FFR and OCT assessment - MVD \> 2 50% angiographic stenosis PCI revascularization strategy based FFR and OCT assessment

Sham comparator: MVD > 2 50% angiographic stenosis PCI revascularization strategy based FFR assessment (and sham OCT) - MVD \> 2 50% angiographic stenosis PCI revascularization strategy based FFR assessment (and sham OCT)


Treatment: Surgery: PCI revascularization strategy based on combined FFR and OCT assessment
PCI revascularization strategy based on combined FFR and OCT assessment All FFR = 0.75 and Vulnerable plaque will be treated. VP defined as TCFA ( cap thickness = 75 micron); Ruptured plaque; or Plaque erosion with \> 70 % AS or MLA \< 2.5 mm2.

Treatment: Surgery: PCI revascularization strategy based FFR assessment
PCI revascularization strategy based FFR assessment (all lesions with FFR=0.80 will be treated)
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
cardiac death, any myocardial infarction (MI) or any clinically-driven revascularization at 24 months
Timepoint [1] 0 0
24 months
Secondary outcome [1] 0 0
Cardiac death, any MI or any clinical-driven revascularization at 24 months excluding TLR events in all lesions with a FFR between 0.76-0.80 left untreated in the experimental arm
Timepoint [1] 0 0
24 months
Secondary outcome [2] 0 0
Cardiac death, any spontaneous MI or any clinically-driven revascularization at 24 months
Timepoint [2] 0 0
24 months

Eligibility
Key inclusion criteria
1. Patients undergoing PCI, aged 30-80 years with any clinical presentation
2. Angiographic criteria: presence of = 2 de novo target lesions* located in 2 different native coronary arteries feasible for treatment with PCI (operator / Heart team decision)

Angiographic criteria target lesion* (all criteria I-IV should be applicable):

I. DS = 50% on visual estimation II. de novo lesion located in native (non-grafted) vessel III. lesion reference diameter of = 2.0 mm IV. Thrombolysis In Myocardial Infarction (TIMI) 3 flow in all vessels (with exclusion of culprit lesions if MI at presentation)

*Target lesions are either culprit MI lesions or lesions where FFR will be performed. Patients are eligible if they have = 2 target lesions or one culprit and = 1 target lesion.
Minimum age
30 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with MVD requiring coronary artery bypass grafting (CABG) treatment (operator / local heart team decision)
2. Lesion located in a grafted segment or in a vein graft
3. In-stent restenosis lesions
4. Left main trifurcation
5. Left main lesion stand-alone (without other lesions)
6. Patients with severe tortuous lesions (where FFR and OCT is judged impossible or dangerous)
7. Chronic total occlusion
8. Spontaneous coronary dissection
9. Patients with severe valvular heart disease likely to require cardiac surgery within the next 2 years
10. Patients with left ventricle (LV) function less than 30%
11. Renal insufficiency (Glomerular Filtration Rate (GFR) < 29 ml/min/1.73m2; Kidney Disease Outcomes Quality Initiative (KDOQI) stage 4 and 5)
12. Life expectancy less than 3 years

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 receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
1222
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Monash Medical - Clayton
Recruitment postcode(s) [1] 0 0
- Clayton
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Montreal
Country [2] 0 0
Canada
State/province [2] 0 0
Ontario
Country [3] 0 0
Denmark
State/province [3] 0 0
Aarhus
Country [4] 0 0
Estonia
State/province [4] 0 0
Tallinn
Country [5] 0 0
France
State/province [5] 0 0
Lille
Country [6] 0 0
France
State/province [6] 0 0
Nancy
Country [7] 0 0
Germany
State/province [7] 0 0
Berlin
Country [8] 0 0
Germany
State/province [8] 0 0
Frankfurt
Country [9] 0 0
India
State/province [9] 0 0
Ahmedabad
Country [10] 0 0
India
State/province [10] 0 0
Bangalore
Country [11] 0 0
India
State/province [11] 0 0
Chandigarh
Country [12] 0 0
Italy
State/province [12] 0 0
Milan
Country [13] 0 0
Italy
State/province [13] 0 0
Rome
Country [14] 0 0
Japan
State/province [14] 0 0
Bunkyo
Country [15] 0 0
Japan
State/province [15] 0 0
Yokohama
Country [16] 0 0
Malaysia
State/province [16] 0 0
Kuala Lumpur
Country [17] 0 0
Netherlands
State/province [17] 0 0
Amsterdam
Country [18] 0 0
Netherlands
State/province [18] 0 0
Dordrecht
Country [19] 0 0
Netherlands
State/province [19] 0 0
Enschede
Country [20] 0 0
Netherlands
State/province [20] 0 0
Tilburg
Country [21] 0 0
New Zealand
State/province [21] 0 0
Wellington
Country [22] 0 0
Poland
State/province [22] 0 0
Katowice
Country [23] 0 0
Poland
State/province [23] 0 0
Krakow
Country [24] 0 0
Poland
State/province [24] 0 0
Lubin
Country [25] 0 0
Poland
State/province [25] 0 0
Warsaw
Country [26] 0 0
Poland
State/province [26] 0 0
Wroclaw
Country [27] 0 0
Romania
State/province [27] 0 0
Bucharest
Country [28] 0 0
Romania
State/province [28] 0 0
Cluj-Napoca
Country [29] 0 0
Romania
State/province [29] 0 0
Targu Mures
Country [30] 0 0
Slovakia
State/province [30] 0 0
Banska Bystrica
Country [31] 0 0
Spain
State/province [31] 0 0
Barcelona
Country [32] 0 0
Spain
State/province [32] 0 0
Madrid
Country [33] 0 0
Spain
State/province [33] 0 0
Santander
Country [34] 0 0
Spain
State/province [34] 0 0
Valencia
Country [35] 0 0
Sweden
State/province [35] 0 0
Linköping
Country [36] 0 0
Sweden
State/province [36] 0 0
Lund
Country [37] 0 0
Sweden
State/province [37] 0 0
Stockholm
Country [38] 0 0
Sweden
State/province [38] 0 0
Örebro
Country [39] 0 0
Taiwan
State/province [39] 0 0
New Taipei City
Country [40] 0 0
Taiwan
State/province [40] 0 0
Taipei City

Funding & Sponsors
Primary sponsor type
Other
Name
Diagram B.V.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Abbott
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Elvin Kedhi, Prof.dr.
Address 0 0
Professor of Medicine McGill University; Director Intervention Cardiology, McGill University Health Center, Canada; Visiting Professor, Silesian Medical University Katowice, Poland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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/NCT05333068