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

Coronary Artery Disease Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02099162
• Other study ID #: 4-2008-0030
• Status: Recruiting
• Start date: August 2007
• Est. completion date: July 2022

Study information

• Verified date: May 2020
• Source: Yonsei University
• Contact: Myeong ki Hong, MD, PhD
• Phone: 082 2 2228 8458
• Email: mkhong61[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Device:
• 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

Locations

Country	Name	City	State
Korea, Republic of	Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine, Seodaemun-gu, Shinchondong	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Clinical outcomes	Death, Cardiac death, Stent thrombosis, Myocardial infarction, Target-lesion revascularization, Target-vessel revascularization	up to 10 years
Primary	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)