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

NCT ID: NCT02099162

Last Updated: 2020-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-08-31

Study Completion Date

2022-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease Ischemic Heart Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine, Seodaemun-gu, Shinchondong

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Myeong ki Hong, MD, PhD

Role: CONTACT

082 2 2228 8458 ext. 88458

Facility Contacts

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Myeong ki Hong, MD, PhD

Role: primary

82-2-2228-8458 ext. 88458

References

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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.

Reference Type DERIVED
PMID: 34023255 (View on PubMed)

Other Identifiers

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4-2008-0030

Identifier Type: -

Identifier Source: org_study_id

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