Prospective, multicenter, randomized controlled study on the efficacy and safety of intravascular ultrasound-guided drug-coated balloon for de novo small-vessel coronary lesions: Design and rationale of the DCB-IVUS trial
Study context
- Population
- Patients indicated for PCI with de novo small-vessel coronary lesions suitable for drug-coated balloon (DCB) treatmentplanned
- Participants
- 998 patients
- Planned comparison
- Intravascular ultrasound (IVUS)-guided DCB vs angiography-guided DCB
- Primary endpoint
- Major adverse cardiac events (MACE):
- Cardiac death
- Target vessel-related MI
- Ischaemia-driven target lesion revascularization
- Follow-up
- 12 months
Methodological detailsdesign and rationale, prospective, multicentre, 1:1 randomisation, Secondary endpoints: all-cause mortality, any MI, ischaemia-driven target vessel revascularization at 12 months; periprocedural angiographic success, clinical procedural success, target vessel drug-eluting stent implantation rate
- Design and rationale
- Prospective
- Multicentre
- 1:1 randomisation
- Secondary endpoints: all-cause mortality, any MI, ischaemia-driven target vessel revascularization at 12 months; periprocedural angiographic success, clinical procedural success, target vessel drug-eluting stent implantation rate
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Prospective, multicenter, randomized controlled study on the efficacy and safety of intravascular ultrasound-guided drug-coated balloon for de novo small-vessel coronary lesions: Design and rationale of the DCB-IVUS trial. Am Heart J. Published 19 November 2025. doi:10.
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