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

Sponsor

Korea University Ansan Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05438121

Collaborator

B. Braun Korea Co., Ltd. (Industry)

Enrollment

Location

42.1

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Atherosclerotic Plaque De Novo Stenosis	Device: SeQuent Please Neo

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 Design

Study Type:

Observational

Anticipated Enrollment :

65 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Drug-Coated Balloon Angioplasty Facilitates Rapid Reduction in Plaque Lipid Burden in Patients With Multivessel Coronary Artery Disease: A Serial NIRS-IVUS Imaging Study

Anticipated Study Start Date :

Jun 30, 2022

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Patients with multivessel CAD undergoing DCB PCI 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)	Device: SeQuent 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.

Arm

Intervention/Treatment

Patients with multivessel CAD undergoing DCB PCI

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)

Device: SeQuent 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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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