Trial Outcomes & Findings for Magnetic Resonance Imaging (MRI) to Assess Radial Artery Compression and Arterial Perfusion While TR Band is Applied (NCT NCT02478671)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

Subjects will be followed up to one week post procedure

Results posted on

2016-03-24

Participant milestones
Measure	TR Band MRI based radial artery measurement
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Withdrawal data not reported

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

Baseline characteristics by cohort
Measure	TR Band n=4 Participants MRI based Radial artery measurement
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	25 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

Timeframe: 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.

Outcome measures
Measure	TR Band n=4 Participants MRI based Radial artery measurement
MRI Based Radial Artery Measurement	1.35 millimeters Interval 0.0 to 2.7

Timeframe: Subjects will be followed up to one week post procedure

pulse oxymetry waveform will be used to measure arterial perfusion

Outcome measures
Measure	TR Band n=4 Participants MRI based Radial artery measurement
Hand Perfusion as Measured by Pulse Oxymetry Waveform	50 percent saturated Interval 0.0 to 100.0

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	TR Band n=4 participants at risk MRI based radial artery measurement
Nervous system disorders Dizziness	25.0% 1/4 • Number of events 1 • from time of procedure until 1 week post procedure

Terumo Medical Corporation

Phone: 732-302-4931

Principal investigator is a sponsor employee PI shall be permitted to publish the results of the Study in a manner that fairly and accurately sets forth the conclusions reached. The party seeking publication shall submit to SPONSOR for review a draft of the proposed publication at least thirty (30) days prior to submission of the draft for publication.
Publication restrictions are in place

Restriction type: OTHER