Coronary Artery DiseaseNCT02099162
Yonsei OCT (Optical Coherence Tomography) Registry for Evaluation of Efficacy and Safety of Coronary Stenting
An observational study of Coronary Artery Disease and Ischemic Heart Disease, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Ischemic Heart Disease
- What is being tested?
- coronary stents
- Type of treatment
- Medical device
- How many people
- 3,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2007to Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who visited our tertiary hostpital (Severance Cardiovascular Hospital) for coronary angiography (with coronary stents or planning for coronary stents)
Who may be able to join
- Patients with coronary stents
- Patients who will have coronary stents because of coronary artery stenosis
Who cannot join
- Hemodynamically unstable patients
- Ostial lesions that begin within 15 mm of the left main coronary artery
- Lesions with diameter more than 4 mm
- Patients with allergy to antiplatelet agent (asprin or clopidogrel)
- Patients with hepatic dysfunction (Liver enzyme 3 times the upper limit of normal)
- Pregnant and lactating patients
- Patients with life expectancy less than 1 year
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine, Seodaemun-gu, Shinchondong
Seoul, 120-752
Myeong ki Hong, MD, PhD, 82-2-2228-8458 ext. 88458, mkhong61@yuhs.ac
About this study
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.
- Conditions
- Coronary Artery Disease, Ischemic Heart Disease
- Being tested
- coronary stents
- Keywords
- OCT, Coronary, Stenting
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronary stentsDevice
e.g. Sirolimus eluting stent, Paclitaxel-eluting stent, Zotarolimus-eluting stent, Everolimus-eluting stent, Biolimus eluting stent, EPC(endothelial progenitor cell) Capture stent, etc
What is being measured
The primary outcome is the main question the study is designed to answer.
OCT findings (stented lesions, native vessels)
Measured: at index PCI, at follow-up coronary angiography (3, 6, 9 or 12 months and at the time clinically indicated)
Clinical outcomes
Death, Cardiac death, Stent thrombosis, Myocardial infarction, Target-lesion revascularization, Target-vessel revascularization
Measured: up to 10 years
Comparison of OCT findings with physiologic findings
Measured: at index PCI, at follow-up coronary angiography (3, 6, 9 or 12 months and at the time clinically indicated)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startAug 2007
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02099162
- Sponsor's protocol ID
- 4-2008-0030
- Status last verified
- May 2020
- First submitted
- 25 Mar 2014
- Last updated
- 18 May 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34023255
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yonsei OCT (Optical Coherence Tomography) Registry for Evaluation of Efficacy and Safety of Coronary Stenting
- ClinicalTrials.gov ID
- NCT02099162
- Acronym / sponsor ID
- 4-2008-0030
- Conditions
- Coronary Artery Disease, Ischemic Heart Disease
- Keywords
- OCT, Coronary, Stenting
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Aug 2007 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 28 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who visited our tertiary hostpital (Severance Cardiovascular Hospital) for coronary angiography (with coronary stents or planning for coronary stents)
Key inclusion criteria (2 listed)
- Patients with coronary stents
- Patients who will have coronary stents because of coronary artery stenosis
Key exclusion criteria (7 listed)
- Hemodynamically unstable patients
- Ostial lesions that begin within 15 mm of the left main coronary artery
- Lesions with diameter more than 4 mm
- Patients with allergy to antiplatelet agent (asprin or clopidogrel)
- Patients with hepatic dysfunction (Liver enzyme 3 times the upper limit of normal)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coronary stentse.g. Sirolimus eluting stent, Paclitaxel-eluting stent, Zotarolimus-eluting stent, Everolimus-eluting stent, Biolimus eluting stent, EPC(endothelial progenitor cell) Capture stent, etc | Device | – |
Primary outcome
OCT findings (stented lesions, native vessels)
Time frame: at index PCI, at follow-up coronary angiography (3, 6, 9 or 12 months and at the time clinically indicated)
Clinical outcomes
Time frame: up to 10 years
Death, Cardiac death, Stent thrombosis, Myocardial infarction, Target-lesion revascularization, Target-vessel revascularization
Comparison of OCT findings with physiologic findings
Time frame: at index PCI, at follow-up coronary angiography (3, 6, 9 or 12 months and at the time clinically indicated)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2020.
- Derived from this study: PubMed 34023255Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Ischemic Heart Disease, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Myeong ki Hong, MD, PhD (082 2 2228 8458 ext. 88458, mkhong61@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OCT findings (stented lesions, native vessels) (time frame: at index PCI, at follow-up coronary angiography (3, 6, 9 or 12 months and at the time clinically indicated)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02099162, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2020.