Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000143527
Ethics application status
Approved
Date submitted
18/01/2024
Date registered
15/02/2024
Date last updated
15/02/2024
Date data sharing statement initially provided
15/02/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prospective Australasian National Bifurcation Coronary Intervention Outcomes Registry
Scientific title
Prospective Australasian National Bifurcation Coronary Intervention Outcomes Registry comparing provisional strategy to 2 stent strategy.
Secondary ID [1] 311453 0
None
Universal Trial Number (UTN)
Trial acronym
ABC Registry
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bifurcation Coronary Artery Disease 332621 0
Condition category
Condition code
Cardiovascular 329321 329321 0 0
Coronary heart disease
Surgery 329467 329467 0 0
Surgical techniques

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
2
Target follow-up type
Years
Description of intervention(s) / exposure
All patients recruited to this study require a stenting procedure as clinically indicated to coronary disease occurring at a bifurcation. Patients will present with stable angina, acute coronary syndromes, or other indications, and need to have severe coronary disease either angiographically or based on functional assessment. Patient selection and the technique will be left completely at the discretion of the operator, with a provisional (one-stent) technique and a 2-stent technique being the main bifurcation stenting sub-groups. Participants will be asked to provide informed consent after being provided a patient information sheet and the opportunity to discuss questions about the study. Patients will receive a phone call at 3 months, 1 year and 2 years to assess if they have any symptoms or presentations to hospital which may indicate target lesion failure.
Intervention code [1] 327799 0
Not applicable
Comparator / control treatment
2 stent technique
Control group
Active

Outcomes
Primary outcome [1] 337135 0
What is the incidence of Major Adverse Cardiovascular Events (MACE) of a provisional strategy compared to a 2 stent strategy
Timepoint [1] 337135 0
2 years after stenting procedure
Secondary outcome [1] 430840 0
Incidence of cardiac death using provisional strategy compared to a 2 stent strategy.
Timepoint [1] 430840 0
2 years after stenting procedure
Secondary outcome [2] 430841 0
Incidence of target lesion revascularisation using provisional strategy compared to a 2 stent strategy.
Timepoint [2] 430841 0
2 years after stenting procedure
Secondary outcome [3] 430842 0
Incidence of Target vessel-related myocardial infarction using a provisional strategy compared to a 2 stent strategy.
Timepoint [3] 430842 0
2 years after stenting procedure
Secondary outcome [4] 430843 0
Incidence of Stent Thrombosis using a provisional strategy compared to a 2 stent strategy.
Timepoint [4] 430843 0
2 years after stenting procedure
Secondary outcome [5] 430844 0
Incidence of utilisation of intra-vascular imaging during bifurcation PCI
Timepoint [5] 430844 0
At time of procedure

Eligibility
Key inclusion criteria
-18 years and older.
-Coronary bifurcation according to the Medina classification of bifurcations (1,1,1; 1,0,0; 1,1,0; 1,0,1; 0,1,1; 0,1,0).
-Main branch diameter greater than or equal to 2.5mm and side branch diameter greater than or equal to 2mm.
-Lesion severity greater than or equal to 70% stenosis, positive pressure wire assessment (FFR less than or equal to 0.8; iFR<0.9), culprit lesion for ST-elevation myocardial infarction (STEMI) or Non-STEMI (NSTEMI), or positive functional assessment in the territory being revascularized.
-Treated with either a provisional or 2 stent strategy.
-Treated with drug-eluting stents.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age less than 18 years
Cardiogenic Shock
Allergy/intolerance to anti-platelet medication
Less than 1 year expected survival
Active bleeding disorder

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
Categorical data will be analysed using student t-test, and continuous variables will be analysed with regression analysis. Where appropriate, survival analysis, including Kaplan-Meier estimates will be used.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
21/08/2023
Date of last participant enrolment
Anticipated
1/01/2028
Actual
Date of last data collection
Anticipated
1/01/2030
Actual
Sample size
Target
1750
Accrual to date
15
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 26087 0
New Zealand
State/province [1] 26087 0

Funding & Sponsors
Funding source category [1] 315612 0
Charities/Societies/Foundations
Name [1] 315612 0
Heart Research Australia
Country [1] 315612 0
Australia
Funding source category [2] 315614 0
Commercial sector/Industry
Name [2] 315614 0
Terumo
Country [2] 315614 0
Australia
Funding source category [3] 315615 0
Commercial sector/Industry
Name [3] 315615 0
Abbott Vascular
Country [3] 315615 0
Australia
Funding source category [4] 315616 0
Commercial sector/Industry
Name [4] 315616 0
Medtronic
Country [4] 315616 0
Australia
Funding source category [5] 315617 0
Commercial sector/Industry
Name [5] 315617 0
Philips
Country [5] 315617 0
Australia
Funding source category [6] 315618 0
Commercial sector/Industry
Name [6] 315618 0
Boston Scientific
Country [6] 315618 0
Australia
Primary sponsor type
Government body
Name
Northern Sydney Local Health District
Address
Royal North Shore Hospital, Reserve Rd, St Leonards, NSW 2065
Country
Australia
Secondary sponsor category [1] 317709 0
None
Name [1] 317709 0
None
Address [1] 317709 0
Country [1] 317709 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314500 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 314500 0
NSLHD Research Office, Level 13 Kolling Building, Royal North Shore Hospital, Reserve Road, St Leonards, NSW, 2065
Ethics committee country [1] 314500 0
Australia
Date submitted for ethics approval [1] 314500 0
05/09/2022
Approval date [1] 314500 0
06/02/2023
Ethics approval number [1] 314500 0
2022/ETH01864

Summary
Brief summary
Despite the substantial volume of bifurcation PCI which is performed in ANZ, there is no local registry in which procedural techniques, device usage, and outcomes are documented. The study is observational in nature only, with PCI selection and technique will be left at the discretion of the operator. Eligible subjects will be enrolled into the registry after providing informed consent. Medical records review and phone call follow up will be performed to assess for the incidence of the primary and secondary outcome at 72hrs (medical record only), 3 months, 1 year and 2 years.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131806 0
Prof Ravinay Bhindi
Address 131806 0
Department of Cardiology, Level 5, Royal North Shore Hospital, Reserve Rd, St Leonards, NSW 2065
Country 131806 0
Australia
Phone 131806 0
+6129463 2525
Fax 131806 0
Email 131806 0
[email protected]
Contact person for public queries
Name 131807 0
Dr Dr Avedis Ekmejian
Address 131807 0
Department of Cardiology, Level 5, Royal North Shore Hospital, Reserve Rd, St Leonards, NSW 2065
Country 131807 0
Australia
Phone 131807 0
+61 299267111
Fax 131807 0
Email 131807 0
[email protected]
Contact person for scientific queries
Name 131808 0
Dr Avedis Ekmejian
Address 131808 0
Department of Cardiology, Level 5, Royal North Shore Hospital, Reserve Rd, St Leonards, NSW 2065
Country 131808 0
Australia
Phone 131808 0
+61 299267111
Fax 131808 0
Email 131808 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.