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

NCT02984891 | Terminated

• 1 other identifier: AAAQ8295
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease (CAD)

Keywords

Intravascular ultrasound; Optical coherence tomography

Outcome Measures

Primary Outcomes (2)

• Lumen area

  Up to 1 hour

• Luminal diameter

  Up to 1 hour

Study Arms (1)

Treatment

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

Procedure: Optical Coherence Tomography (OCT); Procedure: Intravascular Ultrasound (IVUS)

Interventions

Optical Coherence Tomography (OCT) 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.

Also known as: OCT

Treatment

Intravascular Ultrasound (IVUS) 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.

Also known as: IVUS

Treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients included in the study will be those with coronary artery disease who are scheduled to undergo standard angiography in the cardiac catheterization lab.

You may qualify if:

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

You may not qualify if:

• Significant renal insufficiency

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Tomography, Optical Coherence; Ultrasonography, Interventional

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques; Ultrasonography; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Ziad A. Ali, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 7, 2016
• Study Start: October 6, 2016
• Primary Completion: June 27, 2018
• Study Completion: June 27, 2018
• Last Updated: March 18, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)