STabilization of Atheroma by Lipid-reducing Effect of Drug-Coated Balloon (STABLE-DCB)
Recruiting
Observational Study
Coronary Artery DiseaseAtherosclerotic PlaqueDe Novo Stenosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 – 85
Sex
Any
Study type
Observational
Participants needed
65 (estimated)
Sponsor
Korea University Ansan Hospital · Other
Who this trial is looking for
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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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 Criteria…
Inclusion Criteria:
* 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 Criteria:
* 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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