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

Coronary Artery Disease Clinical Trial

— STABLE-DCB  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05438121
• Other study ID #: AAG-O-H-2205
• Status: Recruiting
• Start date: October 13, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2022
• Source: Korea University Ansan Hospital
• Contact: Sunwon Kim, MD, PhD
• Phone: 82-31-8099-6349
• Email: sunwon11[@]hanmail.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerotic Plaque
• Coronary Artery Disease
• Coronary Disease
• De Novo Stenosis
• Myocardial Ischemia
• Plaque, Atherosclerotic

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Korea University Ansan Hospital	Ansan-si	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Korea University Ansan Hospital	B. Braun Korea Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference of serially-assessed lipid core burden index (LCBI) change between DCB-treated lesion vs. medically-treated lesion	?LCBI: NIRS-assessed changes in LCBI between baseline and follow-up.	6~9 month
Secondary	Difference of serially-assessed plaque burden change between DCB-treated lesion vs. medically-treated lesion.	?Plaque burden: IVUS-assessed changes in plaque burden between baseline and follow-up.	6~9 month