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

NCT ID: NCT04523168

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-28
• Study Completion Date: 2023-07-28

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.

Conditions

Coronary Microvascular Dysfunction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chronic Refractory Angina

Subjects with chronic refractory angina will undergo implantation of the Neovasc Reducer™ System in the cardiac catheterization laboratory.

Group Type: EXPERIMENTAL

The Neovasc Reducer™ System

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amir Lerman

OTHER

Sponsor Role: lead

Responsible Party

Amir Lerman

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Amir Lerman

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20-006386

Identifier Type: -

Identifier Source: org_study_id