Chronic refractory angina pectoris untreatable chest pain
Conditions
Interventions
None listed
Sponsors
Neovasc Medical, Inc
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Arm 1: • Symptomatic CAD with chronic refractory angina pectoris classified as CCS grade II, III or IV despite attempted optimal medical therapy • Subject has limited treatment options for revascularization by CABG or by PCI • Evidence of reversible myocardial ischemia in at least one of the following objective clinical tests performed up to 6 months prior to consent: Thallium/Methoxyisobutyl Isonitrile (MIBI) Single Photon Emission Computed Tomography (SPECT), Dobutamine Stress Echo (DSE), Perfusion magnetic resonance imaging (MRI), Exercise Tolerance Testing (ETT) • Left ventricular ejection fraction (LVEF) greater than or equal to 30% • Male or non-pregnant female (If required by institutional procedures, females of childbearing potential must have a negative pregnancy test)Arm 2: • Subjects previously implanted in the Reducer (treatment) arm of the COSIRA studyArm 3: • Subjects in whom the Reducer was implanted under CE Mark (unrelated to the COSIRA study), prior to enrollment in the REDUCER-I studyAll Arms: • Subject has been informed about the study and provides written informed consent prior to enrollment • Subject is willing to comply with specified follow-up evaluations and can be contacted by telephone
Exclusion criteria
Exclusion criteria: Arm 1: • Recent (within three months) acute coronary syndrome • Recent (within six months) PCI or CABG • Unstable angina (recent onset angina, crescendo angina, or rest angina with electrocardiogram [ECG] changes) during the 30 days prior to baseline • Decompensated congestive heart failure (CHF) or hospitalization due to CHF during the three months prior to baseline • Life threatening rhythm disorders or any rhythm disorders that would require placement of an internal defibrillator and / or pacemaker • Severe chronic obstructive pulmonary disease (COPD) as indicated by a forced expiratory volume in one second that is less than 55% of the predicted value • Subject cannot undergo exercise tolerance test or 6-minute walk test for reasons other than refractory angina • Severe valvular heart disease • Subject with pacemaker or defibrillator electrode in the right atrium (RA), right ventricle (RV), or CS • Subject having undergone tricuspid valve replacement or repair • Chronic renal failure (serum creatinine >2 mg/dL), including subjects on chronic hemodialysis • Moribund subjects, or subjects with comorbidities limiting life expectancy to less than one year • Contraindication to required medications that cannot be adequately controlled with pre-medication • Known allergy to stainless steel or nickel • Currently enrolled in another device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpointsAngiographic Exclusion • Mean right atrial pressure greater than or equal to 15 mmHg • ubject with anomalous or abnormal CS as demonstrated by angiogram. Abnormality defined as: • Abnormal CS anatomy (e.g., tortuosity, aberrant branch, persistent left superior vena cava [SVC]) and/or; • CS diameter at the site of planned Reducer implantation less than 9.5 mm or greater than 13 mm• Mean right atrial pressure greater than or equal to 15 mmHg • Subject with anomalous or abnormal CS as demonstrated by angiogram. Abnormality defined as: • Abnormal CS anatomy (e.g., tortuosity, aberrant branch, persistent left superior vena cava [SVC]) and/or; • CS diameter at the site of planned Reducer implantation less than 9.5 mm or greater than 13 mm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of subjects who experience improvement in their angina symptoms defined as a reduction in CCS grade, at 6 months as compared to baseline The rate of occurrence of device and / or procedure related periprocedural Serious Adverse Events (SAEs) defined as a composite of death, myocardial infarction (MI), cardiac tamponade, clinically-driven re-dilation of a Reducer, lifethreatening arrhythmias (ventricular tachycardia [VT] or ventricular fibrillation [VF]), and respiratory failure through 30 days post-implant Major Adverse Cardiac Events (MACE): a composite of cardiac death, major stroke, and MI through 30 days post implant | — |
Secondary
| Measure | Time frame |
|---|---|
| The percentage of subjects who experience improvement in their angina symptoms defined as a reduction in CCS grade at 12 months and annually through 5 years post implant as compared to baseline Major Adverse Cardiac Events (MACE): a composite of cardiac death, major stroke, and MI at 6 months, 12 months and annually through 5 years post implant | — |
Countries
Netherlands
Outcome results
None listed