NCT02099162

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
6.7 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 28, 2014

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

May 18, 2020

Status Verified

May 1, 2020

Enrollment Period

14.9 years

First QC Date

March 25, 2014

Last Update Submit

May 13, 2020

Conditions

Coronary Artery DiseaseIschemic Heart Disease

Keywords

OCTCoronaryStenting

Outcome Measures

Primary Outcomes (3)

  • 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

    Death, Cardiac death, Stent thrombosis, Myocardial infarction, Target-lesion revascularization, Target-vessel revascularization

    up to 10 years

  • 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)

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who visited our tertiary hostpital (Severance Cardiovascular Hospital) for coronary angiography (with coronary stents or planning for coronary stents)

You may qualify if:

  • Patients with coronary stents
  • Patients who will have coronary stents because of coronary artery stenosis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine, Seodaemun-gu, Shinchondong

Seoul, 120-752, South Korea

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34023255DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial Ischemia

Condition Hierarchy (Ancestors)

Coronary DiseaseHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Myeong ki Hong, MD, PhD

CONTACT

082 2 2228 8458mkhong61@yuhs.ac

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2014

First Posted

March 28, 2014

Study Start

August 1, 2007

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

May 18, 2020

Record last verified: 2020-05

Locations

KR(1)