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

Coronary Microvascular Dysfunction Clinical Trial

— Reducer  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04523168
• Other study ID #: 20-006386
• Status: Completed
• Phase: N/A
• Start date: June 28, 2021
• Est. completion date: July 28, 2023

Study information

• Verified date: September 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 28, 2023
• Est. primary completion date: July 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 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

Related Conditions & MeSH terms

• Coronary Microvascular Dysfunction

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Amir Lerman

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Coronary Flow Reserve (CFR)	Calculated as the ratio of hyperemic to rest coronary blood flow	Baseline, 4 months post Reducer implantation
Primary	Change in Index of Myocardial Resistance (IMR)	Calculated as the ratio of coronary pressure divided by coronary blood flow at maximal hyperemia	Baseline, 4 months post Reducer implantation

External Links

•   Mayo Clinic Clinical Trials