Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04523168
Other study ID # 20-006386
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
Study type Interventional

Clinical Trial Summary

This study is being done to evaluate the role of a novel implantable device, called The Neovasc Reducerâ„¢ 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

Study Design


Related Conditions & MeSH terms

  • Coronary Microvascular Dysfunction

Intervention

Device:
The Neovasc Reducerâ„¢ 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
See also
  Status Clinical Trial Phase
Completed NCT06306066 - Coronary Thermo-dilution Derived Flow-indices in Chronic Coronary Syndrome
Recruiting NCT05288361 - The DISCOVER INOCA Prospective Multi-center Registry
Terminated NCT04614467 - A Placebo-Controlled Trial of CLBS16 in Subjects With Coronary Microvascular Dysfunction Phase 2
Recruiting NCT06089031 - Belgian Registry on Coronary Function Testing
Enrolling by invitation NCT06083155 - The NetherLands Registry of Invasive Coronary Vasomotor Function Testing (NL-CFT)
Completed NCT05009667 - A Prospective, Multi-center Clinical Trial for Evaluating the Effectiveness and Safety of Online Coronary Angiography-Derived Index of Microcirculatory Resistance (caIMR)
Active, not recruiting NCT05197361 - Microvascular Coronary Resistance and Absolute Coronary FLOW in Patients With Percutaneous Intervention of a Chronic Total Occlusion
Not yet recruiting NCT06332131 - Effects of Immune Checkpoint Inhibitors on Coronary Microvasculature
Recruiting NCT05825339 - Absolute Flow for Ischemia With No Obstructive Coronary Arteries
Recruiting NCT05294887 - Randomized Trial to Examine a Differential Therapeutic Response in Symptomatic Patients With Non-obstructive Coronary Artery Disease Phase 4
Not yet recruiting NCT05790876 - Super Saturated Oxygen (SSO2) Therapy in Patients With ST-segment Elevation Myocardial Infarction (STEMI) and Action on Coronary Microcirculation Dysfunction N/A
Completed NCT04959357 - The Evaluation of Left Ventricular Systolic Function in Different Types of Ischemic Heart Disease
Recruiting NCT06393478 - Southeastern Europe Microcirculation Registry
Recruiting NCT05711719 - Vericiguat in Patients With Metabolic Syndrome and Coronary Vascular Dysfunction Phase 2
Recruiting NCT06294730 - COronary Microcirculation and Troponin Elevation in Septic Shock
Recruiting NCT05841485 - COVID-19 Microvascular Evaluation Trial
Recruiting NCT03876223 - Women's Ischemia Syndrome Evaluation (WISE) Pre-HFpEF
Completed NCT05471739 - Simultaneous Assessment of Coronary Microvascular Dysfunction and Ischemia With Non-obstructed Coronary Arteries With Intracoronary Electrocardiogram and Intracoronary Doppler
Completed NCT02333591 - Effect of Intact GLP-1 (7-36) and GLP-1 Metabolite (9-36) on Coronary and Peripheral Vascular Function in Adults Phase 4
Completed NCT01014949 - Microcirculation Assessment in Diabetes and Metabolic Syndrome N/A

External Links