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Clinical Trials/NCT04523168
NCT04523168
Completed
N/A

A Phase II Study Testing the Feasibility and Efficacy of Coronary Sinus Narrowing in Patients With Coronary Microvascular Dysfunction

Amir Lerman1 site in 1 country30 target enrollmentJune 28, 2021
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ConditionsCoronary Microvascular Dysfunction

Overview

Phase
N/A
Intervention
Not specified
Conditions
Coronary Microvascular Dysfunction
Sponsor
Amir Lerman
Enrollment
30
Locations
1
Primary Endpoint
Change in Coronary Flow Reserve (CFR)
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 28, 2021
End Date
July 28, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Amir Lerman
Responsible Party
Sponsor Investigator
Principal Investigator

Amir Lerman

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in Coronary Flow Reserve (CFR)

Time Frame: 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 Outcomes

  • Change in Canadian Cardiovascular Society (CCS) Angina Class(Baseline, 120 days)
  • Seattle Angina Questionnaire (SAQ)(120 days)

Study Sites (1)

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