Atherosclerotic Plaque, Coronary Artery Disease, De Novo Stenosis
Conditions
Keywords
drug coated balloon, Near infrared spectroscopy, NIRS-IVUS, De novo coronary lesion
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.
Interventions
DEVICESeQuent Please Neo
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.
Sponsors
B. Braun Korea Co., Ltd.
Korea University Ansan Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference of serially-assessed lipid core burden index (LCBI) change between DCB-treated lesion vs. medically-treated lesion | 6~9 month | ΔLCBI: NIRS-assessed changes in LCBI between baseline and follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference of serially-assessed plaque burden change between DCB-treated lesion vs. medically-treated lesion. | 6~9 month | ΔPlaque burden: IVUS-assessed changes in plaque burden between baseline and follow-up. |
Countries
South Korea
Contacts
Primary ContactSunwon Kim, MD, PhD
Outcome results
None listed