Drug-Coated Balloon Angioplasty Facilitates Rapid Reduction in Plaque Lipid Burden in Patients with Multivessel Coronary Artery Disease: a Serial NIRS-IVUS Imaging Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Korea University Ansan Hospital
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- Difference of serially-assessed lipid core burden index (LCBI) change between DCB-treated lesion vs. medically-treated lesion
- Status
- Recruiting
- Last Updated
- last year
Overview
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 (NIRS) at 6-9 months following the index procedure.
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 plaques, it takes time for such beneficial effects to appear. This study aims to investigate whether DCB angioplasty can effectively modify de novo coronary atherosclerotic plaque and lead to reduction in plaque lipid burden as assessed by near infrared spectroscopy (NIRS) at 6-9 months following the index procedure.
Investigators
Sunwon Kim
Sunwon Kim, MD, PhD, Associate professor
Korea University Ansan Hospital
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
- •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
Outcomes
Primary Outcomes
Difference of serially-assessed lipid core burden index (LCBI) change between DCB-treated lesion vs. medically-treated lesion
Time Frame: 6~9 month
ΔLCBI: NIRS-assessed changes in LCBI between baseline and follow-up.
Secondary Outcomes
- Difference of serially-assessed plaque burden change between DCB-treated lesion vs. medically-treated lesion.(6~9 month)