An interventional study of AngioDefender in Cardiovascular Diseases, sponsored by Everist Genomics, Inc. Completed at 2 sites in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-05.
Sponsored by Everist Genomics, Inc · Not applicable, Interventional, and Diagnostic
The objective of this study is to define the repeatability and reproducibility of quantifying flow-mediated dilation (FMD) of the brachial artery (BA) using the AngioDefender (AD) methodology.
Repeatability will be assessed by repeat AD testing of the same subject 1 hour apart, using the same AD device and operator.
Reproducibility will be assessed by comparing FMD scores obtained for the same subject, but using different AD devices and operators.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 920 are open to participants now.
This study's enrollment of 20 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Everist Genomics, Inc is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The AngioDefender device uses a novel, proprietary software algorithm to analyze pulse wave amplitude data collected before and after brachial artery occlusion by a standard upper arm pneumatic blood pressure cuff. The procedure is non-invasive and does not employ ultrasound.
Device: AngioDefender
Repeatability will be assessed by repeat AngioDefender (AD) testing of the same subject 1 hour apart, using the same AD device and operator. Reproducibility will be assessed by comparing FMD scores obtained for the same subject, but using different AD devices and operators.
Change from baseline %flow-mediation dilation (%FMD) at 1 hour
Repeat AD testing of the same subject 1 hour apart on 4 consecutive days (operators and/or AD devices change each day)
Time frame: Daily x 4 consecutive days
Reproducibility of multiple %FMD determinations by AngioDefender
Repeat AD testing of the same subject over 4 consecutive days using different operators and/or AD devices each day
Time frame: Daily x 4 consecutive days
Incidence of emergent adverse device effects (ADEs) according to CTCAE v4.03
Spontaneous ADEs reported by the subject and inquiry into emergence of expected/unexpected ADEs
Time frame: 4 consecutive days (maximum 5 days)
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Everist Genomics, Inc