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

Korea University Ansan Hospital

Status: Enrolling

Conditions: Coronary Artery Disease; De Novo Stenosis; Atherosclerotic Plaque

Treatments: Device: SeQuent Please Neo

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05438121

AAG-O-H-2205

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

65 participants in 1 patient group

Patients with multivessel CAD undergoing DCB PCI

Description:

I. Patients with significant multi-vessel coronary artery disease will be screened. II. If the patient is found to have at least one lipid-rich plaque (LRP, LCBI>250) requiring revascularization (DS>70%) will undergo multi-vessel IVUS-NIRS imaging. III. If multi-vessel NIRS screening revealed another LRP (LCBI>250) with DS<70%, the patient will be enrolled. IV. The stenotic LRP lesion (DS>70%) will be subjected to DCB angioplasty while non-stenotic LRP lesion (DS<70%) will be left unintervened and treated medically. V. Comparative lesions: DCB-treated LRP (DS>70%, maxLCBI>250) Unintervened, medically-treated LRP (DS<70%, maxLCBI>250)

Treatment:

Device: SeQuent Please Neo