Chronic refractory angina pectoris untreatable chest pain.
Conditions
Interventions
Patients that fullfill all criteria will be randomized to:
• Reducer Group: right heart catheterization as the last screening test,
followed by Reducer implantation, and completion of the catheteriza
Sponsors
Neovasc Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - older than 18 - Symptomatic CAD with chronic refractory angina pectoris classified as Canadian Cardiovascular Society grade III of IV despite attempted optimal medical therapy for three months prior to screening - Patient has limited treatment options for revascularization by coronary artery bypass grafting or by percutaneous coronary intervention - Evidence of reversible ischemia that is atributable to the left coronary arterial system - At least 1 mm ST-segment depression at baseline exercise testing - Left ventricular ejection fraction greater than 25% - Written informed consent prior to enrollment - Patient is willing to comply
Exclusion criteria
Exclusion criteria: - Recent (within three months) acute coronary syndrome - Recent (within six months) PCI or CABG - Unstable angina (recent onset angina, crescendo angina, of rest angina with ECG changes) during the thirty days prior to screening. - De-compensated congestive heart failure (CHF) of hospitalisation due to CHF during the Three months prior to screening - Life threatening rhythm disorders of 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 predictec value - Patient cannot undergo exercise stress test (treadmill) for reasons other than refractory angina - Sever valvular heart disease - Patient with pacemaker or defibrillator electrode in the right atrium, right ventricle, or coronary sinus - Chronic renal failure (serum creatinine >2 mg/dL), including patients on chronic hemodyalisis - Moribund patients, or patients with comorbidities limiting life expectancy to less than one year - Contrainciation to required study medications that cannot be adequately controlled with pre-medication - Known allergy to stainless steel or nickel - Conainciation to having an MRI performed (NB: Cardiac MRI subset patients only) - CUrrently enrolled in another investigational device or drug trial has not completed the primary endpoint or that clinically interferes with the current study endpoints;Angiographic - Mean right atrial pressure higher than or equal to 15 mmHg - Patient with anomalous or abnormal CS as demonstrated by angiogram, Abnormality definec as: * abnormal CS anatomy (e.g., tortuosity, aberrant branch, persistent left 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 |
|---|---|
| CCS Angina Pectoris Classification: a decrease in two or more CCS angina pectoris grades from baseline to six-month post-procedural evaluation in Reducer and Control groups | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Technical success: in the Reducer group, defined as successful delivery and deployment of the Reducer to the intended site as assessed by the investigator 2. Procedural success: in the Reducer group, defined as technical success and the absence of acute need for clinically -driven intervention to address an Adverse or Serious Adverse Device Effect prior to hospital discharge, as adjudicated by the Clinical Events Committee (CEC) 3. Periprocedural Serious Adverse Event (SAE): in the Reducer group, defined as a composite of death, myocardial infarction (MI), cardiac tamponade, clinically-driven re-dilation of a failed Reducer, life-threatening arrhythmias (ventricular tachycardia [VT] or ventricular fibrillation [VF]), and respiratory failure through 30 days post-procedure, as adjudicated by the CEC 4. Periprocedural SAE: in the Control group, defined as a composite of death, MI, cardiac tamponade, life-threatening arrhythmias (VT or VF), and respiratory failure through 30 days post-procedure, as adjudicated by the CEC 5. Major Adverse Events: a composite of cardiac death, major stroke, and MI in the Reducer and Control groups through hospital discharge, and at 30-day, three-month, and six-month post-procedural evaluations 6. CCS angina pectoris Classification: a decrease in CCS angina pectoris grades from baseline to six-month post-procedural evaluation in Reducer and Control groups 7. Dobutamine ECHO Wall Motion Score Index (WMSI): in the Reducer and Control groups at baseline and six-month post-procedural evaluation 8. Seattle Angina Questionnaire (SAQ) Score: in the Reducer and Control groups at baseline and six-month postprocedural evaluation 9. Total Exercise Duration (min), Time to ST-Segment Depression (min), and Maximal ST-Segment Depression (mm) by Exercise Stress Test: in the Reducer and Control groups at baseline and six-month post-procedural evaluation | — |
Countries
Netherlands
Outcome results
None listed