Drug-Coated Balloon Angioplasty Facilitates Rapid Reduction in Plaque Lipid Burden in Patients with Multivessel Coronary Artery Disease: a Serial NIRS-IVUS Imaging Study
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• Patients with significant multivessel coronary artery disease requiring revascularization
• Any De novo lesions (reference vessel diameter of 2.25mm\
• 0mm) suitable for DCB angioplasty
• Lesion suitable for intravascular imagings
• Written informed consent
Locations
Other Locations
Republic of Korea
Korea University Ansan Hospital
RECRUITING
Ansan-si
Contact Information
Primary
Sunwon Kim, MD, PhD
sunwon11@hanmail.net
82-31-8099-6349
Time Frame
Start Date: 2022-10-13
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 65
Treatments
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:~1. DCB-treated LRP (DS\>70%, maxLCBI\>250)~2. Unintervened, medically-treated LRP (DS\<70%, maxLCBI\>250)
Related Therapeutic Areas
Sponsors
Collaborators: B. Braun Korea Co., Ltd.
Leads: Korea University Ansan Hospital