Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001145291
Ethics application status
Approved
Date submitted
26/06/2018
Date registered
12/07/2018
Date last updated
12/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cardiac Stent Study: A prospective observational registry study.
Scientific title
Cone flare crush modified T stent bifurcation registry: A prospective observational registry study.
Secondary ID [1] 295319 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CFCT Study
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Bifurcation Stenosis 308513 0
Coronary Artery Disease 308514 0
Condition category
Condition code
Cardiovascular 307484 307484 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
12
Target follow-up type
Months
Description of intervention(s) / exposure
Standard of care bifurcation stenting will occur. Patients will be observed post-procedure for 12 months for any cardiovascular outcomes. Visits will occur at Discharge, 30 days, 6 months and 12 months. The participant will be reviewed by their cardiologist at each visit.
Intervention code [1] 301646 0
Not applicable
Comparator / control treatment
There is no comparator group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306459 0
Composite outcome of cardiac related mortality, non-fatal myocardial infarction, target lesion or target vessel revascularisation and stroke (as per Academic Research Consortium definitions, Outcome will be measured by participant reports and medical records.
Timepoint [1] 306459 0
30 days, 6 months, 12 months.
Secondary outcome [1] 348620 0
Cardiac related mortality. Data will be ascertained via medical records review and participant reporting.
Timepoint [1] 348620 0
Discharge, 30 days, 6 months, 12 months.
Secondary outcome [2] 348673 0
All-cause mortality. Data will be ascertained via medical records review.
Timepoint [2] 348673 0
Assessed for the duration of the study (12 months).
Secondary outcome [3] 348674 0
3. Stent thrombosis (acute, sub-acute, late and very late; definite, probable and possible). Data will be ascertained via medical records review and participant reporting.
Timepoint [3] 348674 0
Assessed for the duration of the study (12 months).
Secondary outcome [4] 349350 0
Non-fatal myocardial infarction. Data will be ascertained via medical records review and participant reporting.
Timepoint [4] 349350 0
Assessed for the duration of the study (12 months).
Secondary outcome [5] 349351 0
Target lesion or target vessel revascularisation. Data will be ascertained via medical records review and participant reporting.
Timepoint [5] 349351 0
Assessed for the duration of the study (12 months).
Secondary outcome [6] 349353 0
Stroke. Data will be ascertained via medical records review and participant reporting.
Timepoint [6] 349353 0
Assessed for the duration of the study (12 months).

Eligibility
Key inclusion criteria
• Age equal to or greater than 18yrs
• Planned two-stent bifurcation technique using a platinum chromium everolimus drug eluting stent with abluminal bioresorbable drug eluting polymer for a bifurcation stenosis where the side-branch is 2.5 mm or greater in diameter and the operator has determined a two stent CFCT technique is required
• Non-emergent setting
• ACS patients included if undergoing a staged procedure
• Written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients in whom the insertion of a bifurcation stent is not clinically indicated
• Patients in whom the insertion of a bifurcation stent is not clinically advised (for example inability to take dual antiplatelet therapy because of bleeding diathesis).
• Patients undergoing primary PCI for ST elevation myocardial infarction or rescue PCI for failed fibrinolysis
• Women of childbearing potential with a positive pregnancy test.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The analysis will include the application of statistical methods appropriate for the interrogation of a prospective cohort data-set including Kaplan-Meier analysis in addition to univariate and multivariate logistic regression analytics.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
11/04/2018
Date of last participant enrolment
Anticipated
10/04/2020
Actual
Date of last data collection
Anticipated
9/04/2021
Actual
Sample size
Target
20
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 11239 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 23112 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 299908 0
Commercial sector/Industry
Name [1] 299908 0
Boston Scientific Corporation Australia and New Zealand
Country [1] 299908 0
Australia
Primary sponsor type
Hospital
Name
Princess Alexandra Hospital
Address
Ipswich Road
Woolloongabba
QLD 4102
Country
Australia
Secondary sponsor category [1] 299277 0
None
Name [1] 299277 0
Address [1] 299277 0
Country [1] 299277 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300777 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 300777 0
Ethics committee country [1] 300777 0
Australia
Date submitted for ethics approval [1] 300777 0
14/09/2017
Approval date [1] 300777 0
03/10/2017
Ethics approval number [1] 300777 0
HREC/17/QPAH/627

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

Contacts
Principal investigator
Name 84786 0
Dr Anthony Camuglia
Address 84786 0
Cardiology Department
Princess Alexandra Hospital
Ipswich Road
Woolloongabba
QLD 4102
Country 84786 0
Australia
Phone 84786 0
+61731765145
Fax 84786 0
+61731765065
Email 84786 0
ACamuglia@heartcarepartners.com.au
Contact person for public queries
Name 84787 0
Cindy Hall
Address 84787 0
Cardiology Department
Princess Alexandra Hospital
Ipswich Road
Woolloongabba
QLD 4102
Country 84787 0
Australia
Phone 84787 0
+61731765145
Fax 84787 0
+61731765065
Email 84787 0
cindy.hall@health.qld.gov.au
Contact person for scientific queries
Name 84788 0
Anthony Camuglia
Address 84788 0
Cardiology Department
Princess Alexandra Hospital
Ipswich Road
Woolloongabba
QLD 4102
Country 84788 0
Australia
Phone 84788 0
+61731765145
Fax 84788 0
+61731765065
Email 84788 0
ACamuglia@heartcarepartners.com.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes ‘The Cone Flare Crush Modified-T (CFCT) Stenting T... [More Details] 375432-(Uploaded-15-06-2021-15-02-08)-Journal results publication.pdf

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe Cone Flare Crush Modified-T (CFCT) stenting technique for coronary artery bifurcation lesions.2020https://dx.doi.org/10.1016/j.ijcha.2020.100643
N.B. These documents automatically identified may not have been verified by the study sponsor.