Magnetic Resonance Imaging (MRI) to Assess Radial Artery Compression and Arterial Perfusion While TR Band is Applied

Not Applicable

Completed

• Conditions: Poor Peripheral Perfusion
• Interventions: Device: TR Band

• Registration Number: NCT02478671
• Lead Sponsor: Terumo Medical Corporation

Brief Summary

Subjects' radial artery diameters and plethysmography waveforms will be recorded by MRI and pulse oxymetry at varying levels of radial artery compression by the Terumo TR Band.

Detailed Description

In this study, the diameter of each subjects' radial artery will be measured using MRI imagery at varying degrees of radial artery compression by adjusting the amount of air injected into a Terumo TR Band. In addition, using pulse oxymetry, the perfusion waveform will be measured and recorded also while the subjects have a TR Band in place on their wrists.

Study Timeline

• Study First Submitted: 2015-05-19
• Study Start: 2015-06
• Study First Submitted QC: 2015-06-18
• Study First Posted: 2015-06-23
• Primary Completion: 2015-07
• Study Completion: 2015-08
• Results First Submitted: 2015-11-30
• Status Verified: 2016-02
• Results First Submitted QC: 2016-02-24
• Last Update Submitted: 2016-02-24
• Results First Posted: 2016-03-24
• Last Update Posted: 2016-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

1. Female or male adult (has reached the legal majority age).
2. Subject has provided his/her written informed consent to participate in the trial prior to any study -related procedure being conducted.

Exclusion Criteria

1. Abnormal result of either baseline Barbeau or reverse Barbeau tests.
2. Pregnant or breast feeding female.
3. Subject with contraindication to MRI

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TR Band	TR Band	Each subject will have a Terumo TR Band applied to the wrist with MRI scans done at differing band pressure levels. The diameter of the radial artery will be measured at each level of band compression.

Primary Outcome Measures

Name	Time	Method
MRI Based Radial Artery Measurement	Subjects will be followed up to one week post procedure	Each subject's radial artery will be measured using MRI at varying levels of pressure within the TR Band.

Secondary Outcome Measures

Name	Time	Method
Hand Perfusion as Measured by Pulse Oxymetry Waveform	Subjects will be followed up to one week post procedure	pulse oxymetry waveform will be used to measure arterial perfusion