RecruitingACTRN12625001349437

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

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.

Sponsor

Sydney Local Health District

Enrollment

198 participants

Start Date

Dec 1, 2025

Study Type

Interventional

Conditions

Obstructive coronary artery disease

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

When blood vessels in the heart become narrowed by fatty plaques, doctors can treat them using balloon angioplasty — a procedure where a tiny balloon is inflated inside the artery to open it up. One increasingly popular approach uses a 'drug-coated balloon' (DCB), which releases medication directly into the artery wall to prevent it from narrowing again. Before the DCB is used, the artery must first be prepared with a regular balloon to ensure the drug can penetrate effectively. This trial compares three different preparation methods — a scoring balloon, a cutting balloon, and a standard non-compliant balloon — to find out which one does the best job of opening up the artery before drug delivery. The main measure is the minimum lumen area (the smallest cross-section of the opened artery), checked with an ultrasound device placed inside the vessel. You may be eligible if you are 18 or older and have a new (de novo) blockage in a native coronary artery that is suitable for drug-coated balloon treatment. People with total blockages, heavy clot burden, or blockages requiring specialised calcium-removal devices would not be eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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 produc

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.

Locations(2)

Singapore

New Zealand

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