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RECRUITINGOBSERVATIONAL

Efficacy and Safety of Zotarolimus-eluting Stent Overexpansion With OCT

In vivO Study of assessmeNt for Efficacy and safetY of Zotarolimus-eluting Stent OVERexpansion With Optical Coherence Tomography (ONYSOVER Trial)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Investigators aimed to evaluate efficacy and safety of expansion capacity of zotarolimus-eluting Stent assessed by optical coherence tomography (OCT) in vivo study.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DEVICE

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.

DEVICE

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