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

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

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 Overview

• Status: Completed
• Conditions: Coronary Microvascular Dysfunction
• Intervention / Treatment: Device: The Neovasc Reducer™ System

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• Age >18
• Able to provide written informed consent and willing to participate in all required study follow-up assessments
• Symptomatic CAD with refractory angina defined as CCS class II to IV, despite optimal tolerated medical therapy
• Abnormal coronary microvascular function indices: CFR≤2.5 and/or IMR≥25

Exclusion Criteria

• Recent (within 3 months) acute coronary syndrome
• Patients with prior coronary artery bypass surgery
• Unstable angina (recent onset angina, crescendo angina, or rest angina with ECG changes) during the last 30 days
• Subjects in cardiogenic shock (systolic pressure < 80mm/Hg, on vasopressors or intraaortic counter pulsation) at the time of consenting. Subjects who recover from cardiogenic shock by the time of consenting are eligible.
• Obstructive CAD on coronary angiography (>70% stenosis or 50-70% stenosis with iFR<0.89 or FFR<0.8 in epicardial artery)
• Inability to perform invasive coronary flow evaluation and/or measure CFR and IMR in the LAD
• Severe valvular heart disease
• LVEF<30%
• Decompensated congestive heart failure (CHF) or hospitalization due to CHF during the last 3 months
• Patient with a pacemaker electrode in the CS
• Mean right atrial pressure >15 mmHg
• Anomalous or abnormal CS anatomy (e.g., tortuosity, aberrant branch, persistent left superior vena cava (SVC) as demonstrated on angiogram
• CS diameter at the site of planned implantation greater than 13mm or less than 9.5 mm as measured by angiogram
• Severe chronic obstructive pulmonary disease (COPD) indicated by a forced expiratory volume in one second that is less than 55 percent of the predicted value
• Tricuspid valve replacement or repair (tissue or mechanical)
• Chronic renal failure (serum creatinine >2mg/dL), and or on chronic hemodialysis
• Moribund, or with comorbidities limiting life expectancy to less than one year
• Known severe reaction to required procedural medication
• Known allergy to stainless steel or nickel
• Magnetic Resonance Imaging (MRI) within 8 weeks of Reducer implantation
• Participation in another ongoing investigational trial
• Additional factors deemed unsuitable for trial enrollment per discretion of principal investigator
• Inmates

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chronic Refractory Angina; Subjects with chronic refractory angina will undergo implantation of the Neovasc Reducer™ System in the cardiac catheterization laboratory.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 120 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	Baseline, 120 days

Collaborators and Investigators

• Sponsor: Amir Lerman
• Investigators: Principal Investigator: Amir Lerman, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2021
• Primary Completion (Actual): July 28, 2023
• Study Completion (Actual): July 28, 2023

Study Registration Dates

• First Submitted: August 19, 2020
• First Submitted That Met QC Criteria: August 19, 2020
• First Posted (Actual): August 21, 2020

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: July 29, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 20-006386

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes