Late-lumen Changes After Drug-Coated Balloon Angioplasty Versus Drug-Eluting Stents in De Novo Coronary Lesions
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This study aims to compare late-lumen loss (LLL) between DCB and DES to treat de novo coronary artery stenosis by intravascular ultrasound (IVUS).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:
• Subject must be at least 19 years of age
• Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily
• Patients with at least one lesion with greater than 50% diameter stenosis or fractional flow reserve ≤0.80 requiring revascularization in de-novo coronary artery of reference vessel size ≥3.0 mm
Locations
Other Locations
Republic of Korea
Kosin University Gospel Hospital
NOT_YET_RECRUITING
Busan
Keimyung University Dongsan Hospital
NOT_YET_RECRUITING
Daegu
Chonnam National University
RECRUITING
Gwangju
Jeonbuk National University Hospital
NOT_YET_RECRUITING
Jeonju
Ewha Womans University Mokdong Hospital
NOT_YET_RECRUITING
Seoul
Korea University Guro Hospital
NOT_YET_RECRUITING
Seoul
Samsung Medical Center
NOT_YET_RECRUITING
Seoul
Ulsan University Hospital
NOT_YET_RECRUITING
Ulsan
Yeosu Jeil Hospital
NOT_YET_RECRUITING
Yeosu
Contact Information
Primary
Seung Hun Lee, MD, PhD
lsh8602@naver.com
+82-62-220-6246
Backup
Joon Ho Ahn, MD, PhD
yhbky@naver.com
+82-62-220-5778
Time Frame
Start Date: 2025-08-18
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 256
Treatments
Active_comparator: Drug-eluting stent
In DES group, latest second-generation DES will be used in accordance with standard practice guideline.
Experimental: Drug-coated balloon
In DCB group, commercially available DCB (Agent, Boston Scientific, USA) will be used. DCB angioplasty will be recommended as follows to fully optimized procedural results. First, DCB size should be 1:1 ratio with reference vessel size. Second, delivery time of DCB should be within 30 seconds. Third, total inflation time of DCB will be recommended from 30 to 60 seconds.
Related Therapeutic Areas
Sponsors
Collaborators: Boston Scientific Corporation
Leads: Chonnam National University Hospital