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Efficacy and Safety of Zotarolimus-eluting Stent Overexpansion With OCT

NCT05340361 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2026-04-24

No results posted yet for this study

Summary

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

Conditions

Interventions

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

Sponsors & Collaborators

  • Severance Hospital

    collaborator OTHER

  • Medtronic

    collaborator INDUSTRY

  • Yonsei University

    lead OTHER

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-23
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • South Korea

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05340361 on ClinicalTrials.gov