← Back to Clinical Trials
Recruiting NCT05438121

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

Trial Parameters

Condition Coronary Artery Disease
Sponsor Korea University Ansan Hospital
Study Type OBSERVATIONAL
Phase N/A
Enrollment 65
Sex ALL
Min Age 18 Years
Max Age 85 Years
Start Date 2022-10-13
Completion 2025-06-30
Interventions
SeQuent Please Neo

Brief 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.

Eligibility Criteria

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 Trials