AngioDefender Versus Brachial Artery Ultrasound Imaging

Status:	Completed
Conditions:	Peripheral Vascular Disease, Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	2/3/2018
Start Date:	August 2015
End Date:	February 15, 2017

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

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.

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

We found this trial at

sites

Boston University

One Silber Way
Boston, Massachusetts 02215

(617) 353-2000