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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02099162
Enrollment
3000
Registered
2014-03-28
Start date
2007-08-31
Completion date
2022-07-31
Last updated
2020-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Ischemic Heart Disease

Keywords

OCT, Coronary, Stenting

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.

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

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 outcomesup to 10 yearsDeath, Cardiac death, Stent thrombosis, Myocardial infarction, Target-lesion revascularization, Target-vessel revascularization
Comparison of OCT findings with physiologic findingsat index PCI, at follow-up coronary angiography (3, 6, 9 or 12 months and at the time clinically indicated)

Countries

South Korea

Contacts

Primary ContactMyeong ki Hong, MD, PhD
mkhong61@yuhs.ac082 2 2228 8458

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026