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| Name | Class |
|---|---|
| B. Braun Korea Co., Ltd. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Difference of serially-assessed plaque burden change between DCB-treated lesion vs. medically-treated lesion. | ΔPlaque burden: IVUS-assessed changes in plaque burden between baseline and follow-up. | 6~9 month |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with significant multi-vessel coronary artery disease requiring revascularization
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sunwon Kim, MD, PhD | Contact | 82-31-8099-6349 | sunwon11@hanmail.net |
| Name | Affiliation | Role |
|---|---|---|
| Sunwon Kim, MD, PhD | Korea University Ansan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Ansan Hospital | Recruiting | Ansan-si | Gyeonggi-do | 15355 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22027722 | Background | 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. | |
| 31565793 | 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. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D058226 | Plaque, Atherosclerotic |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 32138967 | 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. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |