ANZCTR - Registration

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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]

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

Coronary Artery Disease

Condition category

Condition code

Cardiovascular

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]

Not applicable

Comparator / control treatment

There is no comparator group.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

30 days, 6 months, 12 months.

Secondary outcome [1]

Cardiac related mortality. Data will be ascertained via medical records review and participant reporting.

Timepoint [1]

Discharge, 30 days, 6 months, 12 months.

Secondary outcome [2]

All-cause mortality. Data will be ascertained via medical records review.

Timepoint [2]

Assessed for the duration of the study (12 months).

Secondary outcome [3]

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]

Assessed for the duration of the study (12 months).

Secondary outcome [4]

Non-fatal myocardial infarction. Data will be ascertained via medical records review and participant reporting.

Timepoint [4]

Assessed for the duration of the study (12 months).

Secondary outcome [5]

Target lesion or target vessel revascularisation. Data will be ascertained via medical records review and participant reporting.

Timepoint [5]

Assessed for the duration of the study (12 months).

Secondary outcome [6]

Stroke. Data will be ascertained via medical records review and participant reporting.

Timepoint [6]

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]

Princess Alexandra Hospital - Woolloongabba

Recruitment postcode(s) [1]

4102 - Woolloongabba

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Boston Scientific Corporation Australia and New Zealand

Address [1]

191 O'Riorodan Street
Mascot
NSW 2020

Country [1]

Australia

Primary sponsor type

Hospital

Name

Princess Alexandra Hospital

Address

Ipswich Road
Woolloongabba
QLD 4102

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Metro South Human Research Ethics Committee

Ethics committee address [1]

37 Kent Street
Woolloongabba
QLD 4102

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/09/2017

Approval date [1]

03/10/2017

Ethics approval number [1]

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

Dr Anthony Camuglia

Address

Cardiology Department
Princess Alexandra Hospital
Ipswich Road
Woolloongabba
QLD 4102

Country

Australia

Phone

+61731765145

Fax

+61731765065

Email

[email protected]

Contact person for public queries

Name

Ms Cindy Hall

Address

Cardiology Department
Princess Alexandra Hospital
Ipswich Road
Woolloongabba
QLD 4102

Country

Australia

Phone

+61731765145

Fax

+61731765065

Email

[email protected]

Contact person for scientific queries

Name

Dr Anthony Camuglia

Address

Cardiology Department
Princess Alexandra Hospital
Ipswich Road
Woolloongabba
QLD 4102

Country

Australia

Phone

+61731765145

Fax

+61731765065

Email

[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

Current Study Results

No documents have been uploaded by study researchers.

Update to Study Results

Doc. No.	Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
4716	Study results article	Yes		‘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

Source	Title	Year of Publication	DOI
Embase	The Cone Flare Crush Modified-T (CFCT) stenting technique for coronary artery bifurcation lesions.	2020	https://dx.doi.org/10.1016/j.ijcha.2020.100643

N.B. These documents automatically identified may not have been verified by the study sponsor.