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AngioDefender Versus Brachial Artery Ultrasound Imaging | Clinical Trials | Clareo Health

COMPLETEDNA

AngioDefender Versus Brachial Artery Ultrasound Imaging

Vascular Reactivity Assessment by a Novel Diagnostic Device, ANGIODEFENDER, Compared to Using Brachial Artery Ultrasound Imaging

NCT02468336•Everist Genomics, Inc

View on ClinicalTrials.gov

Summary

The objective of this study is to demonstrate that the investigational device, AngioDefender, is comparable to the established procedure referred to as 'brachial artery ultrasound imaging' in their abilities to quantify flow-mediated vasodilation of the brachial artery.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•ECOG 0-2

Exclusion Criteria

•1. Body mass index (BMI) \>50 kg/m2
•2. Mid-upper arm circumference of arm selected for FMD testing \<17 cm or \>40 cm
•3. Sinus arrhythmia (RR intervals vary by \>50%), atrial fibrillation, atrial flutter, multifocal atrial tachycardia, frequent (\>1 per 10-sec strip) premature atrial or ventricular contractions (isolated, non-isolated, or alternating), documented by 12-lead ECG with rhythm strip at the time of subject screening.
•4. Clinical signs and/or symptoms of active viral or bacterial infections
•5. Resting tremor or inability to remain still for the duration of AD and BAUI testing
•6. Systolic blood pressure (SBP) at rest of \>170 mmHg or diastolic blood pressure (DBP) at rest of ≥110 mmHg.
•7. Previous intolerable adverse reaction(s) to vascular testing using an upper extremity occlusive pneumatic cuff

Locations (5)

University of Colorado, Boulder

Boulder, Colorado, United States

Yale University Prevention Research Center

Derby, Connecticut, United States

Boston University

Boston, Massachusetts, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

University of Western Ontario

London, Ontario, Canada

Key Dates

Start Date

August 1, 2015

Primary Completion Date

February 15, 2017

Completion Date

February 15, 2017

Last Updated

February 1, 2018

Enrollment

171

ACTUAL participants

Conditions

Cardiovascular Diseases

Interventions

AngioDefender

DEVICE

Ultrasound

DEVICE

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Cardiovascular DiseasesCardiac Rehabilitation

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 1, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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AngioDefender Versus Brachial Artery Ultrasound Imaging

Inclusion Criteria

Exclusion Criteria

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