Efficacy and Safety of Zotarolimus-eluting Stent Overexpansion With OCT

Launched by YONSEI UNIVERSITY · Apr 17, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a special type of heart stent called a zotarolimus-eluting stent. The researchers want to find out how well this stent can expand in the arteries of patients diagnosed with coronary artery disease, which is when the heart's blood vessels are narrowed or blocked. They will use a technique called optical coherence tomography (OCT), a type of imaging, to closely observe the stent's performance inside the body.

To be part of this study, participants need to be at least 19 years old and have specific heart issues that require a stent, particularly if there is a significant size difference in the arteries being treated. Those interested in joining must agree to participate voluntarily and provide written consent. However, individuals who are allergic to certain medications, women who could become pregnant, or those with a life expectancy of less than one year won’t be eligible. If you join the trial, you can expect to undergo tests with the stent and receive careful monitoring to ensure your safety throughout the study.

Gender

ALL

Eligibility criteria

• 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