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

Terminated

• Conditions: Coronary Artery Disease (CAD)
• Interventions: Procedure: Optical Coherence Tomography (OCT); Procedure: Intravascular Ultrasound (IVUS)

• Registration Number: NCT02984891
• Lead Sponsor: Columbia University

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.

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 Timeline

• Study Start: 2016-10-06
• Study First Submitted: 2016-12-05
• Study First Submitted QC: 2016-12-05
• Study First Posted: 2016-12-07
• Primary Completion: 2018-06-27
• Study Completion: 2018-06-27
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-16
• Last Update Posted: 2021-03-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Luminal diameter	Up to 1 hour
Lumen area	Up to 1 hour

Trial Locations

Locations (1)

Columbia University; 🇺🇸 New York, New York, United States