Status:
RECRUITING
STabilization of Atheroma by Lipid-reducing Effect of Drug-Coated Balloon (STABLE-DCB)
Lead Sponsor:
Korea University Ansan Hospital
Collaborating Sponsors:
B. Braun Korea Co., Ltd.
Conditions:
Coronary Artery Disease
Atherosclerotic Plaque
Eligibility:
All Genders
18-85 years
Brief 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 (...
Detailed Description
A large lipid core is the hallmark of coronary plaques at risk of rupture and subsequent atherothrombosis. Although statin-based medical treatment is known to regress and stabilize lipid-rich coronary...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 13 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT05438121
Start Date
October 13 2022
End Date
December 31 2026
Last Update
October 15 2024
Active Locations (1)
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1
Korea University Ansan Hospital
Ansan-si, Gyeonggi-do, South Korea, 15355