Status:
RECRUITING
Late-lumen Changes After Drug-Coated Balloon Angioplasty Versus Drug-Eluting Stents in De Novo Coronary Lesions
Lead Sponsor:
Chonnam National University Hospital
Collaborating Sponsors:
Boston Scientific Corporation
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
19+ years
Phase:
NA
Brief 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).
Detailed Description
Drug-eluting stent (DES) is the standard of care for patients with coronary artery disease who are eligible for percutaneous coronary intervention (PCI).1 During long-term follow-up, remained metallic...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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
- Exclusion Criteria
- Patients unable to provide consent
- Patients with known intolerance to aspirin, P2Y12 inhibitors, or components of drug-eluting stents
- Patients with angiographic findings of 1) Left main coronary artery disease 2) In-stent restenosis is the cause of target lesion 3) Target lesion in bypass graft 4) True bifurcation lesion that requires upfront 2-stenting
- Patients who have non-cardiac co-morbid conditions with life expectancy \<1 year
- Patients who may result in protocol non-compliance (site investigator's medical judgment)
- Patients with cardiogenic shock or cardiac arrest
- Patients with severe left ventricular systolic dysfunction (ejection fraction \<30%)
- Patients with severe valvular heart disease requiring open heart surgery
- Pregnant or lactating women
Exclusion
Key Trial Info
Start Date :
August 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT06954714
Start Date
August 18 2025
End Date
December 31 2028
Last Update
September 3 2025
Active Locations (9)
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1
Kosin University Gospel Hospital
Busan, South Korea, 49269
2
Keimyung University Dongsan Hospital
Daegu, South Korea, 42601
3
Chonnam National University
Gwangju, South Korea, 61469
4
Jeonbuk National University Hospital
Jeonju, South Korea, 54907