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

Recruiting

• Conditions: Atherosclerotic Plaque; De Novo Stenosis; Coronary Artery Disease
• Interventions: Device: SeQuent Please Neo

• Registration Number: NCT05438121
• Lead Sponsor: Korea University Ansan Hospital

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.

Study Timeline

• Study First Submitted: 2022-06-24
• Study First Submitted QC: 2022-06-24
• Study First Posted: 2022-06-29
• Study Start: 2022-10-13
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-09
• Last Update Posted: 2024-10-14
• Primary Completion: 2025-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with multivessel CAD undergoing DCB PCI	SeQuent Please Neo	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: 1. DCB-treated LRP (DS\>70%, maxLCBI\>250) 2. Unintervened, medically-treated LRP (DS\<70%, maxLCBI\>250)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Korea University Ansan Hospital; 🇰🇷 Ansan-si, Gyeonggi-do, Korea, Republic of