ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12625001349437

Ethics application status

Approved

Date submitted

3/11/2025

Date registered

2/12/2025

Date last updated

2/12/2025

Date data sharing statement initially provided

2/12/2025

Type of registration

Retrospectively registered

Titles & IDs

Public title

SCORE-CUT DCB Trial: A Randomised Comparison of Scoring, Cutting, and Non-Compliant Balloon Lesion Preparation Strategies for Drug-Coated Balloon Angioplasty

Scientific title

SCORE-CUT DCB Trial: A Randomised Comparison of Scoring, Cutting, and Non-Compliant Balloon Lesion Preparation Strategies for Drug-Coated Balloon Angioplasty in Patients with De Novo Coronary Artery Lesions.

Additional trial identifiers [1]

None

Universal Trial Number (UTN)

Trial acronym

Related trial records

Health condition

Health condition(s) studied:

Obstructive coronary artery disease

Condition category

Condition code

Cardiovascular

Coronary heart disease

Intervention/exposure

Study type

Interventional

Description of the intervention or exposure

GROUP 1: Cutting angioplasty balloon
- Participants undergo lesion preparation with a cutting balloon, which has fixed microsurgical blades (atherotomes) on its surface. Low-pressure inflation produces controlled longitudinal micro-incisions in the plaque and intima to facilitate predictable vessel expansion.
• Procedure: Standard coronary intervention via radial/femoral access. After wiring the lesion, the cutting balloon is positioned and inflated one or more times.
• Duration: One-off lesion-prep step; typically involving 5 seconds to 1 minutes total inflation time.
• Anaesthesia: Local anaesthetic at the access site; light intravenous sedation as required.
• Operator: Performed by an interventional cardiologist.
OR
GROUP 2. Scoring angioplasty balloon
Participants undergo lesion preparation with a scoring balloon, which uses helical nitinol scoring elements to apply focused radial force during inflation. This produces controlled, circumferential scoring of the lesion without the deeper incisions produced by cutting blades.
• Procedure: Standard PCI workflow. After wiring, the scoring balloon is positioned and inflated as per protocol.
• Duration: One-off lesion-prep step; typically involving 5 seconds to 1 minutes total inflation time.
• Anaesthesia: Local anaesthetic with optional light intravenous sedation.
• Operator: Performed by an interventional cardiologist.

Intervention code [1]

Treatment: Devices

Description of the comparator or control

Non-compliant balloon
- Participants undergo lesion preparation with a non-compliant (high-pressure) angioplasty balloon. NC balloons are designed to maintain their diameter with minimal expansion even at very high pressures, allowing controlled, high-pressure dilatation of resistant or calcified coronary plaque.
• Procedure:: Standard coronary interventions via radial or femoral access. The operator wires the lesion, positions the NC balloon, and performs high-pressure inflations according to the protocol.
• Duration: One-off lesion-prep step; typically involving 5 seconds to 1 minutes total inflation time.
• Anaesthesia:: Local anaesthetic at the access site with optional light intravenous sedation if clinically appropriate.
• Operator:: Performed by a trained interventional cardiologist.

Control group

Active

Outcomes

Primary outcome [1]

Absolute Minimum Luminal Gain (MLA)

Timepoint [1]

During percutanetous intervention (PCI) case

Secondary outcome [1]

%MLA gain after lesion preparation

Timepoint [1]

During PCI case

Secondary outcome [2]

Final MLA

Timepoint [2]

During PCI case

Secondary outcome [3]

Grade C dissection

Timepoint [3]

During angioplasty case

Secondary outcome [4]

Flow-limiting dissection

Timepoint [4]

During PCI case

Secondary outcome [5]

Plaque Burden

Timepoint [5]

During PCI case

Secondary outcome [6]

%Plaque Burden reduction

Timepoint [6]

During PCI case

Secondary outcome [7]

Thrombolysis in Myocardial Infarction (TIMI) flow

Timepoint [7]

During PCI case

Secondary outcome [8]

Incidence of standardised lesion preparation failure

Timepoint [8]

During PCI Case

Secondary outcome [9]

Incidence of clinical lesion preparation

Timepoint [9]

During PCI case

Secondary outcome [10]

Incidence of coronary perforation

Timepoint [10]

During PCI case

Secondary outcome [11]

Incidence of IVUS catheter delivery failure

Timepoint [11]

During PCI case

Secondary outcome [12]

Incidence of randomised treatment device delivery failure

Timepoint [12]

During PCI case

Secondary outcome [13]

Incidence of bailout stenting

Timepoint [13]

During PCI case

Eligibility

Key inclusion criteria

- Age greater than or equal to 18 years
- De novo lesion in a native coronary artery
- Reference diameter greater than or equal to 2.0mm and less than or equal to 4.0 mm (measured by IVUS)
- Lesion length less than or equal to 30mm (measured by IVUS)
- Lesion suitable for DCB-angioplasty
- Feasibility of pre- and post- lesion IVUS imaging (at least 5mm of vessel pre- and post-lesion

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Healthy volunteers

Key exclusion criteria

- Chronic Total Occlusion
- Heavy thrombus burden
- Lesions requiring calcium modification with intravascular lithotripsy or atherectomy
- Planned bifurcation percutaneous coronary intervention requiring stenting of both main and side branches

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)

No allocation concealment

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

1/12/2025

Date of last participant enrolment

Anticipated

1/03/2027

Actual

Date of last data collection

Anticipated

1/03/2027

Actual

Sample size

Target

198

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment outside Australia

Country [1]

Singapore

State/province [1]

Country [2]

New Zealand

State/province [2]

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Government body

Name

Sydney Local Health District

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney Local Health District Ethics Review Committee (RPAH Zone)

Ethics committee address [1]

https://www.slhd.nsw.gov.au/rpa/research/

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

22/06/2025

Approval date [1]

10/09/2025

Ethics approval number [1]

Summary

Brief summary

Drug-coated balloon (DCB) angioplasty is increasingly recognised as a viable alternative to drug-eluting stents (DES) for selected de novo coronary artery lesions, particularly in scenarios where stent implantation is undesirable. The success of DCB therapy is highly dependent on optimal lesion preparation.. The most commonly used lesion preparation strategies include non-compliant balloons, scoring balloons, and cutting balloons, but head-to-head comparative data in native coronary lesions are lacking.

The primary aim of the SCORE-CUT DCB Trial is to determine the optimal lesion preparation strategy prior to drug-coated balloon (DCB) angioplasty in de novo coronary artery lesions. The trial seeks to compare the final minimal lumen area (MLA), as assessed by intravascular ultrasound (IVUS), among three commonly used preparation techniques: scoring balloon, cutting balloon, and non-compliant (NC) balloon.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Cuneyt Ada

Address

Concord Hospital, Hospital Rd, Concord NSW 2139

Country

Australia

Phone

+61 02 9767 8390

Fax

[email protected]

Contact person for public queries

Name

Dr Chinmay Khandkar

Address

Concord Hospital, Hospital Rd, Concord NSW 2139

Country

Australia

Phone

+61 02 9767 5000

Fax

[email protected]

Contact person for scientific queries

Name

Dr Chinmay Khandkar

Address

Concord Hospital, Hospital Rd, Concord NSW 2139

Country

Australia

Phone

+61 02 9767 5000

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

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.

Trial Review

Documents added manually

Documents added automatically