Coronary Artery Disease Clinical Trial
— STABLE-DCBOfficial 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
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.
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Korea University Ansan Hospital | Ansan-si | Gyeonggi-do |
Lead Sponsor | Collaborator |
---|---|
Korea University Ansan Hospital | B. Braun Korea Co., Ltd. |
Korea, Republic of,
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
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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