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STabilization of Atheroma by Lipid-reducing Effect of Drug-Coated Balloon (STABLE-DCB)

RECRUITINGSponsored by Korea University Ansan Hospital
Actively Recruiting
SponsorKorea University Ansan Hospital
Started2022-10-13
Est. completion2025-06-30
Eligibility
Age18 Years – 85 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05438121

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

Age: 18 Years – 85 YearsHealthy volunteers accepted
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

Conditions4

Atherosclerotic PlaqueCoronary Artery DiseaseDe Novo StenosisHeart Disease

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