Coronary Microvascular Dysfunction
Conditions
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.
Interventions
DEVICEThe 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.
Sponsors
Amir Lerman
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Coronary Flow Reserve (CFR) | Baseline, 120 days | Coronary flow reserve is calculated as the ratio of hyperemic or maximal flow down a coronary vessel to the resting coronary blood flow. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seattle Angina Questionnaire (SAQ) | 120 days | The Seattle Angina Questionnaire (SAQ) is a self-administered, 19-item questionnaire with 5 different subscales - physical limitations, angina stability, angina frequency, treatment satisfaction and quality of life. Each subscale score ranges from 0 to 100, where higher scores indicate better health outcomes. |
| Change in Canadian Cardiovascular Society (CCS) Angina Class | Baseline, 120 days | The Canadian Cardiovascular Society (CCS) Angina Class symptom scale classifies anginal symptoms. Scores range from 1 (best; everyday, regular, physical activity does not cause angina) to 4 (worst; unable to do any regular physical activity without discomfort, anginal symptoms may be present at rest). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Chronic Refractory Angina Subjects with chronic refractory angina will undergo implantation of the Neovasc Reducer™ System in the cardiac catheterization laboratory.
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. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Chronic Refractory Angina |
|---|---|
| Age, Continuous | 54.8 years STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 30 Participants |
| Region of Enrollment United States | 30 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 16 / 30 |
| serious Total, serious adverse events | 2 / 30 |
Outcome results
Primary
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.
Time frame: Baseline, 120 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chronic Refractory Angina | Change in Coronary Flow Reserve (CFR) | 3.04 ratio | Standard Deviation 1.06 |
Comparison: Baseline, 120 daysp-value: 0.0137Wilcoxon (Mann-Whitney)
Secondary
Change in Canadian Cardiovascular Society (CCS) Angina Class
The Canadian Cardiovascular Society (CCS) Angina Class symptom scale classifies anginal symptoms. Scores range from 1 (best; everyday, regular, physical activity does not cause angina) to 4 (worst; unable to do any regular physical activity without discomfort, anginal symptoms may be present at rest).
Time frame: Baseline, 120 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chronic Refractory Angina | Change in Canadian Cardiovascular Society (CCS) Angina Class | 2.40 score on a scale | Standard Deviation 1.1 |
p-value: 0.001Wilcoxon (Mann-Whitney)
Secondary
Seattle Angina Questionnaire (SAQ)
The Seattle Angina Questionnaire (SAQ) is a self-administered, 19-item questionnaire with 5 different subscales - physical limitations, angina stability, angina frequency, treatment satisfaction and quality of life. Each subscale score ranges from 0 to 100, where higher scores indicate better health outcomes.
Time frame: 120 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Refractory Angina | Seattle Angina Questionnaire (SAQ) | Physical limitation score | 62.4 score on a scale | Standard Deviation 26.8 |
| Chronic Refractory Angina | Seattle Angina Questionnaire (SAQ) | Angina stability score | 67.5 score on a scale | Standard Deviation 28.7 |
| Chronic Refractory Angina | Seattle Angina Questionnaire (SAQ) | Angina frequency score | 49.9 score on a scale | Standard Deviation 31.3 |
| Chronic Refractory Angina | Seattle Angina Questionnaire (SAQ) | Treatment satisfaction score | 81.2 score on a scale | Standard Deviation 17.3 |
| Chronic Refractory Angina | Seattle Angina Questionnaire (SAQ) | Quality of life score | 54.7 score on a scale | Standard Deviation 28.4 |