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

NCT05438121 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 65

Last updated 2024-10-15

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • B. Braun Korea Co., Ltd.

    collaborator INDUSTRY

  • Korea University Ansan Hospital

    lead OTHER

Principal Investigators

  • Sunwon Kim, MD, PhD · Korea University Ansan Hospital

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-13
Primary Completion
2025-06-30
Completion
2026-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05438121 on ClinicalTrials.gov