Optical Coherence Tomography (OCT) Intravascular Ultrasound (IVUS) Dual Imaging

Sponsor
Columbia University (Other)
Overall Status
Terminated
CT.gov ID
NCT02984891
Collaborator
(none)
7
1
20.7
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Study Details

Study Description

Brief Summary

Both intravascular ultrasound (IVUS) and optical coherence tomography (OCT) are standardly used and have been extensively studied separately to guide percutaneous coronary intervention and improve long-term outcomes. In this study, the investigators aim to directly compare high-definition IVUS images to OCT in the same patients to determine the differences between each modality as they relate to imaging coronary pathology, with the goal of determining which modality is most appropriate in particular clinical scenarios.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Optical Coherence Tomography (OCT)
  • Procedure: Intravascular Ultrasound (IVUS)

Detailed Description

Intravascular ultrasound (IVUS) is an imaging modality that uses ultrasound waves to allow for detailed evaluation of coronary atherosclerotic plaques and the vascular response to coronary interventional devices to guide stent placement during percutaneous coronary intervention. Current conventional IVUS catheters emit ultrasound waves ranging from 20-40 megahertz (mHz), and more recently released high-definition IVUS catheters emit sound waves at 60 mHz, allowing for better image quality, quantitative accuracy, and precision in measurements.

Optical coherence tomography (OCT) is an alternative imaging modality used for similar purposes as IVUS, using a single optical fiber that emits infrared light to image the coronary artery. OCT uses light in the infrared spectrum with a central wavelength between 1,250 and 1,350 nm. Axial resolution with OCT is 10-20 microns, whereas it is typically 100-200 microns with IVUS. Thus, OCT allows for better image resolution, but this comes at the expense of tissue penetration.

Study Design

Study Type:
Observational
Actual Enrollment :
7 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Dual Imaging Using High-definition Intravascular Ultrasound and Optical Coherence Tomography to Guide Percutaneous Coronary Intervention
Actual Study Start Date :
Oct 6, 2016
Actual Primary Completion Date :
Jun 27, 2018
Actual Study Completion Date :
Jun 27, 2018

Arms and Interventions

Arm Intervention/Treatment
Treatment

Intravascular Ultrasound (IVUS) and Optical Coherence Tomography (OCT) will be used in patients with coronary artery disease.

Procedure: Optical Coherence Tomography (OCT)
Procedure will be performed using the OCT Dragonfly catheter is a hydrophilic-coated catheter that uses infrared light with a central wavelength between 1,250 and 1,350 nm. Axial resolution with OCT is 10-20 microns, and maximum tissue penetration with OCT is approximately 1.5 mm-3 mm.
Other Names:
  • OCT
  • Procedure: Intravascular Ultrasound (IVUS)
    Procedure will be performed using the IVUS Kodama catheter is a hydrophilic-coated catheter that used high-fidelity ultrasound transmission to capture high-definition images of coronary artery anatomy. It uses ultrasound waves with a frequency of 40 or 60 MHz, as opposed to 20 MHz in conventional IVUS, to improve resolution while optimizing tissue penetration. It provides axial resolution of < 40 microns and tissue penetration of 10 mm.
    Other Names:
  • IVUS
  • Outcome Measures

    Primary Outcome Measures

    1. Lumen area [Up to 1 hour]

    2. Luminal diameter [Up to 1 hour]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:
    • Undergone diagnostic coronary angiography

    • Evidence of coronary pathology that requires further imaging to guide treatment

    Exclusion criteria:

    Significant renal insufficiency

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Columbia University New York New York United States 10032

    Sponsors and Collaborators

    • Columbia University

    Investigators

    • Principal Investigator: Ziad A. Ali, MD, Columbia University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Columbia University
    ClinicalTrials.gov Identifier:
    NCT02984891
    Other Study ID Numbers:
    • AAAQ8295
    First Posted:
    Dec 7, 2016
    Last Update Posted:
    Mar 18, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Columbia University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 18, 2021