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Status unknownNCT02099162Updated May 18, 2020

Yonsei OCT (Optical Coherence Tomography) Registry for Evaluation of Efficacy and Safety of Coronary Stenting

An observational study in Coronary Artery Disease and Ischemic Heart Disease, sponsored by Yonsei University. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-18.

Sponsored by Yonsei University · Observational

The sponsor has not verified this record recently (last verified May 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
3,000
Ages
18 Years and older
Sex
All
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Study summary

Optical coherence tomography (OCT) has been recently studied for evaluation of coronary stenting. Because of high resolutions, several reports have shown that OCT is appropriate for evaluating neointimal tissue after coronary stent implantation. Also, the strut coverage and the characterization of neointimal tissue can be accurately evaluated. Furthermore, OCT-defined coverage of a stent strut was proposed to be related with clinical safety in drug-eluting stents-treated patients. Therefore, the investigators will evaluate the appropriateness of currently using coronary stents (e.g. Sirolimus eluting stent, Paclitaxel-eluting stent, Zotarolimus-eluting stent, Everolimus-eluting stent, Biolimus eluting stent, EPC(endothelial progenitor cell) Capture stent, etc) based on the findings of OCT. Additionally, the investigators will evaluate neointimal hyperplasia, malposition or strut coverage to decide the differences in the stent characteristics, the duration of antiplatelet use, and the differences according to the clinical presentations.

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Conditions studied

  • Coronary Artery Disease
  • Ischemic Heart Disease

Keywords

  • OCT
  • Coronary
  • Stenting
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In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's planned enrollment of 3,000 is above the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who visited our tertiary hostpital (Severance Cardiovascular Hospital) for coronary angiography (with coronary stents or planning for coronary stents)

Inclusion criteria

  1. Patients with coronary stents
  2. Patients who will have coronary stents because of coronary artery stenosis

Exclusion criteria

Exclusion Criteria:

  1. Hemodynamically unstable patients
  2. Ostial lesions that begin within 15 mm of the left main coronary artery
  3. Lesions with diameter more than 4 mm
  4. Patients with allergy to antiplatelet agent (asprin or clopidogrel)
  5. Patients with hepatic dysfunction (Liver enzyme 3 times the upper limit of normal)
  6. Pregnant and lactating patients
  7. Patients with life expectancy less than 1 year
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
3,000 participants (estimated)
Patient registry
No

Interventions

  • Devicecoronary stents

    e.g. Sirolimus eluting stent, Paclitaxel-eluting stent, Zotarolimus-eluting stent, Everolimus-eluting stent, Biolimus eluting stent, EPC(endothelial progenitor cell) Capture stent, etc

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What researchers measure

Primary outcomes

  1. OCT findings (stented lesions, native vessels)

    Time frame: at index PCI, at follow-up coronary angiography (3, 6, 9 or 12 months and at the time clinically indicated)

  2. Clinical outcomes

    Death, Cardiac death, Stent thrombosis, Myocardial infarction, Target-lesion revascularization, Target-vessel revascularization

    Time frame: up to 10 years

  3. Comparison of OCT findings with physiologic findings

    Time frame: at index PCI, at follow-up coronary angiography (3, 6, 9 or 12 months and at the time clinically indicated)

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Study locations

1 of 1 sites recruiting
  • Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine, Seodaemun-gu, Shinchondong
    Seoul, 120-752, Korea, Republic of
    Recruiting
08

References and documents

Publications

  • Kim BG, Kachel M, Kim JS, Guagliumi G, Kim C, Kim IS, Lee YJ, Lee OH, Byun YS, Kim BO, Milewski K, Lee SJ, Hong SJ, Ahn CM, Shin DH, Kim BK, Ko YG, Choi D, Jang Y. Clinical Implications of Poststent Optical Coherence Tomographic Findings: Severe Malapposition and Cardiac Events. JACC Cardiovasc Imaging. 2022 Jan;15(1):126-137. doi: 10.1016/j.jcmg.2021.03.008. Epub 2021 May 19. PubMed 34023255 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02099162
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Mar 28, 2014
Start date
Aug 2007
Primary completion
Jul 2022 (estimated)
Completion
Jul 2022 (estimated)
Last update
May 18, 2020

Study contacts

Myeong ki Hong, MD, PhD
Contact
mkhong61@yuhs.ac
082 2 2228 8458 ext. 88458

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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