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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Enrollment
171
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
Statistical equivalence of %FMD determined by AngioDefender vs brachial artery ultrasound imaging (BAUI)
Deming regression analysis and Bland-Altman Plots
Time frame: 1 day
Comparison of types and incidences of emergent adverse device effects
Time frame: 1 day
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University of Western Ontario
London, Ontario, Canada