STabilization of Atheroma by Lipid-reducing Effect of Drug-Coated Balloon (STABLE-DCB)
Drug-Coated Balloon Angioplasty Facilitates Rapid Reduction in Plaque Lipid Burden in Patients with Multivessel Coronary Artery Disease: a Serial NIRS-IVUS Imaging Study
Korea University Ansan Hospital
65 participants
Oct 13, 2022
OBSERVATIONAL
Conditions
Summary
This study aims to investigate whether DCB angioplasty, compared to statin-based medical treatment alone, will lead to more reduction in plaque lipid burden as assessed by near infrared spectroscopy (NIRS) at 6-9 months following the index procedure.
Eligibility
Inclusion Criteria4
- Patients with significant multivessel coronary artery disease requiring revascularization
- Any De novo lesions (reference vessel diameter of 2.25mm~4.0mm) suitable for DCB angioplasty
- Lesion suitable for intravascular imagings
- Written informed consent
Exclusion Criteria6
- Hemodynamically unstable or cardiogenic shock
- Left main stenotic lesion or graft vessel lesion
- Visible angiographic thrombus, not resolved by balloon angioplasty
- Pregnancy or breastfeeding
- Comorbidities with life expectancy < 12 months
- Severe coronary calcification or tortuosity, hindering timely DCB delivery
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Interventions
DCB angioplasty will be performed in accordance with the recent recommendations. Specifically, aggressive lesion predilation (balloon-to-artery ratio: 0.8 to 1.2) using either a plain balloon or a scoring balloon will be performed.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05438121