The purpose of the study is to evaluate the effectiveness of the CADence system, a non-invasive device, in detecting greater than or equal to 50% coronary stenosis anywhere in the coronary tree.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
DOUBLE
Non-invasive detection of \> or equal to 50% stenosis in any of the major coronary arteries.
Iowa Heart Center
Des Moines, Iowa, United States
Mercy Hospital
Coon Rapids, Minnesota, United States
Abbott/Minneapolis Heart Institute
Minneapolis, Minnesota, United States
University of Minnesota
Minneapolis, Minnesota, United States
Efficacy of CADence in detecting greater than or equal to 50% stenosis anywhere in the coronary tree.
The CADence System will be considered to have demonstrated effectiveness in detecting greater than or equal to 50% coronary artery stenosis anywhere in the coronary tree if the estimated sensitivity as compared to angiography is statistically higher than 70%.
Time frame: within three months
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Columbia University
New York, New York, United States
Mt. Sinai
New York, New York, United States
Cheyenne Vascular & Heart Institute
Cheyenne, Wyoming, United States