- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02984891
Optical Coherence Tomography (OCT) Intravascular Ultrasound (IVUS) Dual Imaging
Dual Imaging Using High-definition Intravascular Ultrasound and Optical Coherence Tomography to Guide Percutaneous Coronary Intervention
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10032
- Columbia University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria:
- Undergone diagnostic coronary angiography
- Evidence of coronary pathology that requires further imaging to guide treatment
Exclusion criteria:
Significant renal insufficiency
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Treatment
Intravascular Ultrasound (IVUS) and Optical Coherence Tomography (OCT) will be used in patients with coronary artery disease.
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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:
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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Lumen area
Time Frame: Up to 1 hour
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Up to 1 hour
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Luminal diameter
Time Frame: Up to 1 hour
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Up to 1 hour
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ziad A. Ali, MD, Columbia University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAQ8295
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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