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

Coronary Artery Disease (CAD) Clinical Trial

Official title:

Dual Imaging Using High-definition Intravascular Ultrasound and Optical Coherence Tomography to Guide Percutaneous Coronary Intervention

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02984891
• Other study ID #: AAAQ8295
• Status: Terminated
• Start date: October 6, 2016
• Est. completion date: June 27, 2018

Study information

• Verified date: March 2021
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: June 27, 2018
• Est. primary completion date: June 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion criteria:

• Undergone diagnostic coronary angiography
• Evidence of coronary pathology that requires further imaging to guide treatment Exclusion criteria: Significant renal insufficiency

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Disease (CAD)

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Columbia University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lumen area		Up to 1 hour
Primary	Luminal diameter		Up to 1 hour