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

NCT04523168 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-08-20

Study results available
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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.

Conditions

  • Coronary Microvascular Dysfunction

Interventions

DEVICE

The Neovasc Reducer™ System

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.

Sponsors & Collaborators

  • Amir Lerman

    lead OTHER

Principal Investigators

  • Amir Lerman · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-28
Primary Completion
2023-07-28
Completion
2023-07-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04523168 on ClinicalTrials.gov