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NCT Number: NCT05438121

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerotic Plaque Cardiovascular Diseases Coronary Disease De Novo Stenosis Heart Diseases Myocardial Ischemia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Plaque, Atherosclerotic Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Korea University Ansan Hospital

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

Location status: Recruiting

Location contact

Sunwon Kim, MD, PhD

CONTACT

[email protected]

82-31-8099-6349

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SeQuent Please Neo

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sunwon Kim, MD, PhD

CONTACT

[email protected]

82-31-8099-6349

Sponsors and collaborators

Lead sponsor

Korea University Ansan Hospital

Other

Collaborators

  • B. Braun Korea Co., Ltd.

Registry information

Official study 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

Acronym: STABLE-DCB

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jun 29, 2022
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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