Coronary Artery Disease Clinical Trial
— ONYSOVEROfficial title:
In vivO Study of assessmeNt for Efficacy and safetY of Zotarolimus-eluting Stent OVERexpansion With Optical Coherence Tomography (ONYSOVER Trial)
Investigators aimed to evaluate efficacy and safety of expansion capacity of zotarolimus-eluting Stent assessed by optical coherence tomography (OCT) in vivo study.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | Inclusion Criteria: - Patients, =19 years of age, who were diagnosed with IHD requiring stent implantation for lesion with size discrepancy between proximal and distal reference diameter over 1mm, such as tapered long lesion or bifurcation lesion, confirmed by OCT - The decision to participate voluntarily in this study and the written consent of the patient Exclusion Criteria: - Patients with hypersensitivity or contraindication to antiplatelet treatment - Female of childbearing potential, who possibly plans to become pregnant any time after enrollment into this study. - Patients with a life expectancy shorter than 1 year |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Yongin Severance Hospital | Yongin | Gyeonggi-do |
Lead Sponsor | Collaborator |
---|---|
Yonsei University | Medtronic, Severance Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximal stent overexpansion (%) | defines as the ratio of the maximal stent diameter to each diameter of stent | Through procedure completion, up to 24 hours | |
Secondary | Stent strut fracture | defines as none or fewer visible stent strut on the cross-sectional view by performing OCT within stented segments (In in vivo and in vitro groups) | Through procedure completion, up to 24 hours | |
Secondary | Absolute average stent diameter (mm) in the maximal stent expansion site | Absolute average stent diameter (mm) in the maximal stent expansion site ((In in vivo and in vitro groups) | Through procedure completion, up to 24 hours | |
Secondary | Grade of polymer damage assessed by electron microscope | Grade of polymer damage assessed by electron microscope (In in vitro group) | Through procedure completion, up to 1-month |
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