This study is being done to evaluate the role of a novel implantable device, called The Neovasc Reducer™ System, in improving microvascular function, symptoms and quality of life in symptomatic patients with coronary microvascular dysfunction.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
A stainless-steel mesh pre-mounted on a customized hourglass shaped balloon catheter, is designed to create a focal narrowing in the lumen of the CS to generate a pressure gradient across it.
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Change in Coronary Flow Reserve (CFR)
Coronary flow reserve is calculated as the ratio of hyperemic or maximal flow down a coronary vessel to the resting coronary blood flow.
Time frame: Baseline, 120 days
Seattle Angina Questionnaire (SAQ)
The Seattle Angina Questionnaire (SAQ) is a self-administered, 19-item questionnaire with 5 different subscales - physical limitations, angina stability, angina frequency, treatment satisfaction and quality of life. Each subscale score ranges from 0 to 100, where higher scores indicate better health outcomes.
Time frame: 120 days
Change in Canadian Cardiovascular Society (CCS) Angina Class
The Canadian Cardiovascular Society (CCS) Angina Class symptom scale classifies anginal symptoms. Scores range from 1 (best; everyday, regular, physical activity does not cause angina) to 4 (worst; unable to do any regular physical activity without discomfort, anginal symptoms may be present at rest).
Time frame: Baseline, 120 days
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