Clinical Research Directory
Browse clinical research sites, groups, and studies.
Efficacy and Safety of Zotarolimus-eluting Stent Overexpansion With OCT
Sponsor: Yonsei University
Summary
Investigators aimed to evaluate efficacy and safety of expansion capacity of zotarolimus-eluting Stent assessed by optical coherence tomography (OCT) in vivo study.
Official title: In vivO Study of assessmeNt for Efficacy and safetY of Zotarolimus-eluting Stent OVERexpansion With Optical Coherence Tomography (ONYSOVER Trial)
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
OBSERVATIONAL
Enrollment
30
Start Date
2022-03-23
Completion Date
2026-12-31
Last Updated
2025-11-25
Healthy Volunteers
No
Interventions
Optical coherence tomography-guided percutaneous coronary intervention
OCT examination is performed using a frequency-domain OCT system (C7 Dragonfly OPTIS Imaging Catheter, Abbott Vascular, Santa Clara, CA, USA) with a 5.4 or 7.5 cm total pullback length according to a non-occlusive technique. The procedure is performed via radial or femoral access with a ≥6 Fr guiding catheter. The OCT catheter is advanced over the 0.014-inch PCI wire and the implanted stent was crossed after administration of intracoronary nitrates of 200 µg. For blood clearing, contrast media was injected through the guiding catheter with an automated power injector. The standard infusion rate was 4 mL/s for 4 seconds with 250 PSI. Follow-up OCT image acquisition was achieved with the same method. After post-PCI OCT, we evaluate the factor regarding post-PCI optimization target by European Expert Consensus.
Optical coherence tomography-guided Onyx family stent expansion
1. Expansion of 2.25, 3.0, and 4.0 mm Onyx family stent@ nominal pressure 2. OCT pullback 3. Expansion with over 0.5mm sized non-compliant balloon of each stent 4. OCT pullback 5. Expansion with over 1.0mm sized non-compliant balloon of each stent 6. OCT pullback 7. Expansion with over 1.25\~1.5mm sized non-compliant balloon of each stent 8. OCT pullback 9. Evaluation of polymer status with overexpansion assessed by an electric microscope
Locations (1)
Yongin Severance Hospital
Yongin, Gyeonggi-do, South Korea