Evaluation of Imaging of Peripheral Arteries by Optical Coherence Tomography and Intravascular Ultrasound Imaging

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-24

Study Completion Date

2018-10-01

Brief Summary

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A non inferiority trial to determine the capability of optical coherence tomography (OCT) imaging to show vessel morphology in comparison to imaging provided by intravascular ultrasound imaging (IVUS).

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Detailed Description

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Patients requiring diagnostic imaging of peripheral vessels to determine vessel condition and planning treatment strategy will have vessel segments imaged by both OCT and IVUS imaging catheters. The images will be collected into a library and independent readers will rank each image on the quality of vessel morphology and disease.

Conditions

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Peripheral Artery Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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IVUS Imaging vs. OCT Imaging

A vessel segment will be imaged with intravascular ultrasound (IVUS). The same vessel segment will be imaged with optical coherence tomography (OCT).

Group Type OTHER

IVUS and OCT Imaging

Intervention Type DEVICE

Use of an imaging catheter

Interventions

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IVUS and OCT Imaging

Use of an imaging catheter

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* adult
* suspected vascular disease that might be a candidate for IVUS
* reference vessel can accommodate imaging catheters
* successful diagnostic imaging and removal of IVUS catheter with no adverse events