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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04523168
Recruitment Status : Recruiting
First Posted : August 21, 2020
Last Update Posted : February 3, 2022
Sponsor:
Information provided by (Responsible Party):
Amir Lerman, Mayo Clinic

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronary Microvascular Dysfunction Device: The Neovasc Reducer™ System Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study Testing the Feasibility and Efficacy of Coronary Sinus Narrowing in Patients With Coronary Microvascular Dysfunction
Actual Study Start Date : June 28, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Coronary Flow Reserve (CFR) [ Time Frame: Baseline, 4 months post Reducer implantation ]
    Calculated as the ratio of hyperemic to rest coronary blood flow

  2. Change in Index of Myocardial Resistance (IMR) [ Time Frame: Baseline, 4 months post Reducer implantation ]
    Calculated as the ratio of coronary pressure divided by coronary blood flow at maximal hyperemia


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • Recent (within 6 months) percutaneous coronary intervention revascularization by stent
  • 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 hospitalizatoin 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04523168


Contacts
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Contact: Diana P Albers, BS 507-255-6884 albers.diana2@mayo.edu
Contact: Jacob Bjerke 507-422-0467 bjerke.jacob@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Diana P Albers, BS    507-255-6884    albers.diana2@mayo.edu   
Contact: Jacob Bjerke    507-422-0467    bjerke.jacob@mayo.edu   
Sponsors and Collaborators
Amir Lerman
Investigators
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Principal Investigator: Amir Lerman Mayo Clinic
More Information
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Additional Information:

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Responsible Party: Amir Lerman, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04523168    
Other Study ID Numbers: 20-006386
First Posted: August 21, 2020    Key Record Dates
Last Update Posted: February 3, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes