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

NCT04523168 | Completed Results FDA Device

• 1 other identifier: 20-006386
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Seattle Angina Questionnaire (SAQ)

  120 days

• Change in Canadian Cardiovascular Society (CCS) Angina Class

  Baseline, 120 days

Study Arms (1)

Chronic Refractory Angina

EXPERIMENTAL

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

Device: The Neovasc Reducer™ System

Interventions

The Neovasc Reducer™ System 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.

Chronic Refractory Angina

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Amir Lerman: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Results Point of Contact

• Title: Dr. Amir Lerman
• Organization: Mayo Clinic

lerman.amir@mayo.edu

507-255-2446

Study Officials

• Amir Lerman

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 21, 2020
• Study Start: June 28, 2021
• Primary Completion: July 28, 2023
• Study Completion: July 28, 2023
• Last Updated: August 20, 2024
• Results First Posted: August 20, 2024

Record last verified: 2024-07

Locations

US (1)