Status:
UNKNOWN
Assessment of Cutting-Balloon Angioplasty With Everolimus-Eluting Stent(EES) in the Treatment of Coronary Calcified Lesion(CCL) Guided by Intravascular Ultrasonography(IVUS)
Lead Sponsor:
Soonchunhyang University Hospital
Collaborating Sponsors:
Boston Scientific Corporation
Eulji University
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
19-90 years
Phase:
NA
Brief Summary
The study seeks to address the clinical question of how effectively a novel cutting balloon (Wolverine™) can modify calcified lesions for stent implantation in comparison with a non-compliant (NC) bal...
Detailed Description
1\. Background 1. Which clinical question shall be answered? Heavily calcified lesions respond poorly to conventional balloon angioplasty when stents are implanted in incompletely modified lesions, r...
Eligibility Criteria
Inclusion
- Coronary artery disease including ISR or de novo lesion with a stenosis of ≥ 70%
- Target lesion calcification (an arch of calcium at least 100 degrees) was confirmed by imaging studies
- A reference vessel diameter between 2.0 and 4.0mm and deemed suitable for PCI
Exclusion
- Extremely tortuous or angulated lesions
- Lesions with dissection before balloon pre-dilatation
- Lesions within the vein graft
- Extremely narrow lesions which need to rotational atherectomy
- STEMI
- Comorbidities which preclude the achievement of one year follow up
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06177808
Start Date
January 1 2024
End Date
December 31 2025
Last Update
January 3 2024
Active Locations (1)
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1
Soonchunhyang University Hospital
Bucheon-si, Gyeonggi-do, South Korea, 14584