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

NCT ID: NCT02984891

Last Updated: 2021-03-18

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 7 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-10-06
• Study Completion Date: 2018-06-27

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.

Conditions

Coronary Artery Disease (CAD)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Treatment

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

Optical Coherence Tomography (OCT)

Intervention Type: PROCEDURE

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)

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

OCT; IVUS

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

Significant renal insufficiency

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ziad A. Ali, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University

New York, New York, United States

Countries

United States

Other Identifiers

AAAQ8295

Identifier Type: -

Identifier Source: org_study_id