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

• Conditions: Ischemic Heart Disease; Coronary Artery Disease

• Registration Number: NCT02099162
• Lead Sponsor: Yonsei University

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2014-03-25
• Study First Submitted QC: 2014-03-27
• Study First Posted: 2014-03-28
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-13
• Last Update Posted: 2020-05-18
• Primary Completion: 2022-07
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

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

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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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of OCT findings with physiologic findings	at index PCI, at follow-up coronary angiography (3, 6, 9 or 12 months and at the time clinically indicated)
OCT findings (stented lesions, native vessels)	at index PCI, at follow-up coronary angiography (3, 6, 9 or 12 months and at the time clinically indicated)
Clinical outcomes	up to 10 years	Death, Cardiac death, Stent thrombosis, Myocardial infarction, Target-lesion revascularization, Target-vessel revascularization

Trial Locations

Locations (1)

Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine, Seodaemun-gu, Shinchondong; 🇰🇷 Seoul, Korea, Republic of