Evaluating the effectiveness of zotarolimus-eluting stents using optical coherence tomography
In vivO Study of assessmeNt for Efficacy and safetY of Zotarolimus-eluting Stent OVERexpansion With Optical Coherence Tomography (ONYSOVER Trial)
Yonsei University · NCT05340361
This study is testing if using special stents with a coating can help people with certain heart artery issues have better results during heart procedures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Yonsei University (other) |
| Locations | 1 site (Yongin, Gyeonggi-do) |
| Trial ID | NCT05340361 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the efficacy and safety of zotarolimus-eluting stents during percutaneous coronary interventions, particularly in cases where there is a size discrepancy between proximal and distal reference vessels. The study utilizes optical coherence tomography (OCT) to guide stent implantation and optimize outcomes by accurately measuring vessel dimensions. By focusing on patients with specific coronary artery conditions, the research seeks to improve long-term clinical outcomes through better stent placement techniques. The study will involve single stent implantation and the proximal optimization technique to enhance results in challenging cases.
Who should consider this trial
Good fit: Ideal candidates include patients aged 19 and older with ischemic heart disease requiring stent implantation for lesions with a size discrepancy of over 1mm.
Not a fit: Patients with contraindications to antiplatelet treatment or those with a life expectancy shorter than one year may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved stent placement techniques, resulting in better long-term outcomes for patients with coronary artery disease.
How similar studies have performed: Other studies have shown success with similar optical coherence tomography-guided approaches in stent optimization, indicating a promising avenue for this research.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Yongin, Gyeonggi-do
- Yongin Severance Hospital — Yongin, Gyeonggi-do, Korea, Republic of (RECRUITING)
Study contacts
- Study coordinator: Yongcheol Kim, MD, PhD
- Email: yongcheol@yuhs.ac
- Phone: +82-031-5189-8967
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Coronary Artery Disease, Optical Coherence Tomography, Stent, coronary artery disease, optical coherence tomography, stenting