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

October 9, 2024 updated by: Sunwon Kim, Korea University Ansan Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Ansan-si, Gyeonggi-do, Korea, Republic of, 15355
        • Recruiting
        • Korea University Ansan Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with significant multi-vessel coronary artery disease requiring revascularization

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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:

  1. DCB-treated LRP (DS>70%, maxLCBI>250)
  2. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6~9 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference of serially-assessed plaque burden change between DCB-treated lesion vs. medically-treated lesion.
Time Frame: 6~9 month
ΔPlaque burden: IVUS-assessed changes in plaque burden between baseline and follow-up.
6~9 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea University Ansan Hospital

Collaborators

B. Braun Korea Co., Ltd.

Investigators

  • Principal Investigator: Sunwon Kim, MD, PhD, Korea University Ansan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2022

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

June 24, 2022

First Submitted That Met QC Criteria

June 24, 2022

First Posted (Actual)

June 29, 2022

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 9, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAG-O-H-2205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe