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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05438121
Other study ID # AAG-O-H-2205
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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