Actively Recruiting

Age: 18Years - 85Years
All Genders
NCT05438121

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

Led by Korea University Ansan Hospital · Updated on 2024-10-15

65

Participants Needed

1

Research Sites

220 weeks

Total Duration

On this page

Sponsors

K

Korea University Ansan Hospital

Lead Sponsor

B

B. Braun Korea Co., Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with significant multivessel coronary artery disease requiring revascularization
  • Any de novo lesions with reference vessel diameter of 2.25mm to 4.0mm suitable for DCB angioplasty
  • Lesion suitable for intravascular imaging
  • Written informed consent
Not Eligible

You will not qualify if you...

  • 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 less than 12 months
  • Severe coronary calcification or tortuosity hindering timely DCB delivery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Korea University Ansan Hospital

Ansan-si, Gyeonggi-do, South Korea, 15355

Actively Recruiting

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Research Team

S

Sunwon Kim, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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