Feasibility and Efficacy of Coronary Sinus Narrowing in Patients With Coronary Microvascular Dysfunction

Not Applicable

Completed

• Conditions: Coronary Microvascular Dysfunction
• Interventions: Device: The Neovasc Reducer™ System

• Registration Number: NCT04523168
• Lead Sponsor: Amir Lerman

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-19
• Study First Submitted QC: 2020-08-19
• Study First Posted: 2020-08-21
• Study Start: 2021-06-28
• Primary Completion: 2023-07-28
• Study Completion: 2023-07-28
• Status Verified: 2024-07
• Results First Submitted: 2024-07-29
• Results First Submitted QC: 2024-07-29
• Last Update Submitted: 2024-07-29
• Results First Posted: 2024-08-20
• Last Update Posted: 2024-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chronic Refractory Angina	The Neovasc Reducer™ System	Subjects with chronic refractory angina will undergo implantation of the Neovasc Reducer™ System in the cardiac catheterization laboratory.

Primary Outcome Measures

Name	Time	Method
Change in Coronary Flow Reserve (CFR)	Baseline, 120 days	Coronary flow reserve is calculated as the ratio of hyperemic or maximal flow down a coronary vessel to the resting coronary blood flow.

Secondary Outcome Measures

Name	Time	Method
Change in Canadian Cardiovascular Society (CCS) Angina Class	Baseline, 120 days	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).
Seattle Angina Questionnaire (SAQ)	120 days	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States