Clinical trial NCT02099162: Yonsei OCT (Optical Coherence Tomography) Registry for Evaluation of Efficacy and Safety of Coronary Stenting
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Ischemic Heart Disease
Keywords: OCT
Coronary
Stenting
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-03-28
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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)

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.


Eligibility criteria: 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

Primary outcomes:
measure: OCT findings (stented lesions, native vessels)
timeFrame: at index PCI, at follow-up coronary angiography (3, 6, 9 or 12 months and at the time clinically indicated)
measure: Clinical outcomes
timeFrame: up to 10 years
measure: Comparison of OCT findings with physiologic findings
timeFrame: at index PCI, at follow-up coronary angiography (3, 6, 9 or 12 months and at the time clinically indicated)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine, Seodaemun-gu, Shinchondong
Study officials:
References:
citation: 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.