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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Drug-Coated Balloon Angioplasty Facilitates Rapid Reduction in Plaque Lipid Burden in Patients With Multivessel Coronary Artery Disease: A Serial NIRS-IVUS Imaging Study

Conditions
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Coronary Artery Disease, Atherosclerotic Plaque, De Novo Stenosis

Intervention / Treatment
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* Device: SeQuent Please Neo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with multivessel CAD undergoing DCB PCI<br>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: DCB-treated LRP (DS>70%, maxLCBI>250) Unintervened, medically-treated LRP (DS<70%, maxLCBI>250) | Device: SeQuent Please Neo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug coated balloon, Near infrared spectroscopy, NIRS-IVUS, De novo coronary lesion