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.
Sydney Local Health District
198 participants
Dec 1, 2025
Interventional
Conditions
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
Inclusion Criteria6
- 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
Exclusion Criteria4
- 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
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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 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)
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ACTRN12625001349437