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
37 Kent Street
Woolloongabba
QLD 4102
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
Patients undergoing bifurcation coronary stenting as part of standard of care and who give informed consent will be included in this study.
All of the following are part of standard of care:
Participants will be seen in pre-admission clinic or in their hospital bed by the PI. The registry will be discussed and if agreeable informed consent will be obtained. The participant will have a bifurcation stent inserted, discharged from hospital and followed up in the clinic at the Princess Alexandra Hospital. An exercise echocardiogram will be performed at Month 12 and if this is positive a coronary angiogram will be performed. The registry then ends for the participant.
Registry research:
Data from all of these time points will be collected.
Trial website
Nil known
Trial related presentations / publications
Nil to date
Public notes
Nil to date

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
[email protected]
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
[email protected]
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
[email protected]

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.