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

NCT05438121 | Recruiting

• 1 other identifier: AAG-O-H-2205
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Atherosclerotic Plaque; De Novo Stenosis

Keywords

drug coated balloon; Near infrared spectroscopy; NIRS-IVUS; De novo coronary lesion

Outcome Measures

Primary Outcomes (1)

• Difference of serially-assessed lipid core burden index (LCBI) change between DCB-treated lesion vs. medically-treated lesion

  ΔLCBI: NIRS-assessed changes in LCBI between baseline and follow-up.

  6~9 month

Secondary Outcomes (1)

• Difference of serially-assessed plaque burden change between DCB-treated lesion vs. medically-treated lesion.

  6~9 month

Study Arms (1)

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

Interventions

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.

Patients with multivessel CAD undergoing DCB PCI

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with significant multi-vessel coronary artery disease requiring revascularization

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea University Ansan Hospital: lead
• B. Braun Korea Co., Ltd.: collaborator

Study Sites (1)

Korea University Ansan Hospital

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

RECRUITING

Related Publications (3)

• Kleber FX, Mathey DG, Rittger H, Scheller B; German Drug-eluting Balloon Consensus Group. How to use the drug-eluting balloon: recommendations by the German consensus group. EuroIntervention. 2011 May;7 Suppl K:K125-8. doi: 10.4244/EIJV7SKA21. No abstract available.

  PMID: 22027722 BACKGROUND

• Her AY, Shin ES, Bang LH, Nuruddin AA, Tang Q, Hsieh IC, Hsu JC, Kiam OT, Qiu C, Qian J, Ahmad WAW, Ali RM. Drug-coated balloon treatment in coronary artery disease: Recommendations from an Asia-Pacific Consensus Group. Cardiol J. 2021;28(1):136-149. doi: 10.5603/CJ.a2019.0093. Epub 2019 Sep 30.

  PMID: 31565793 BACKGROUND

• Yerasi C, Case BC, Forrestal BJ, Torguson R, Weintraub WS, Garcia-Garcia HM, Waksman R. Drug-Coated Balloon for De Novo Coronary Artery Disease: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020 Mar 10;75(9):1061-1073. doi: 10.1016/j.jacc.2019.12.046.

  PMID: 32138967 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Plaque, Atherosclerotic

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Sunwon Kim, MD, PhD

  Korea University Ansan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sunwon Kim, MD, PhD

CONTACT

82-31-8099-6349; sunwon11@hanmail.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sunwon Kim, MD, PhD, Associate professor

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: June 29, 2022
• Study Start: October 13, 2022
• Primary Completion: June 30, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)