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

NCT02478671 | Completed Results

• 1 other identifier: TIS2015-002
• Study Type: interventional
• Target: 4
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Poor Peripheral Perfusion

Outcome Measures

Primary Outcomes (1)

• MRI Based Radial Artery Measurement

  Each subject's radial artery will be measured using MRI at varying levels of pressure within the TR Band.

  Subjects will be followed up to one week post procedure

Secondary Outcomes (1)

• Hand Perfusion as Measured by Pulse Oxymetry Waveform

  Subjects will be followed up to one week post procedure

Study Arms (1)

TR Band

EXPERIMENTAL

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.

Device: TR Band

Interventions

TR Band DEVICE

The radial artery will be compressed using a Terumo TR Band and artery diameter and perfusion will be measured

TR Band

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Terumo Medical Corporation: lead
• Medical University of South Carolina: collaborator

Limitations and Caveats

Single center study with small sample size.

Results Point of Contact

• Title: Robert Gash, Director of Clinical Affairs
• Organization: Terumo Medical Corporation

robert.gash@terumomedical.com

732-302-4931

Study Officials

• Marcelo Guimaraes, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2015
• First Posted: June 23, 2015
• Study Start: June 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: March 24, 2016
• Results First Posted: March 24, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share