Coronary Sinus Reducer for Treatment of Refractory Angina - COSIRA

Launched by SHOCKWAVE MEDICAL, INC. · Sep 20, 2010

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient is older than 18 years of age
• • 2. Symptomatic CAD with chronic refractory angina pectoris classified as Canadian Cardiovascular Society grade III or IV despite attempted optimal medical therapy for thirty days prior to screening
• • 3. Patient has limited treatment options for revascularization by coronary artery bypass grafting or by percutaneous coronary intervention
• • 4. Evidence of reversible ischemia that is attributable to the left coronary arterial system by Dobutamine Echo
• • 5. Left ventricular ejection fraction greater than 25%
• • 6. Male or non-pregnant female (NB: Females of child bearing potential must have a negative pregnancy test)
• • 7. Patient understands the nature of the procedure and provides written informed consent prior to enrollment
• • 8. Patient is willing to comply with specified follow-up evaluation and can be contacted by telephone
• Exclusion Criteria:
• • 1. Recent (within three months) acute coronary syndrome
• • 2. Recent (within six months) successful PCI or CABG
• • 3. Unstable angina (recent onset angina, crescendo angina, or rest angina with ECG changes) during the thirty days prior to screening
• • 4. De-compensated congestive heart failure (CHF) or hospitalization due to CHF during the three months prior to screening
• • 5. Life threatening rhythm disorders or any rhythm disorders that would require placement of an internal defibrillator and or pacemaker
• • 6. 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
• • 7. Patient cannot undergo exercise tolerance test (bicycle) for reasons other than refractory angina
• • 8. Severe valvular heart disease
• • 9. Patient with pacemaker or defibrillator electrode in the right atrium, right ventricle, or coronary sinus
• • 10. Patient having undergone tricuspid valve replacement or repair
• • 11. Chronic renal failure (serum creatinine \>2 mg/dL), including patients on chronic hemodialysis
• • 12. Moribund patients, or patients with comorbidities limiting life expectancy to less than one year
• • 13. Contraindication to required study medications that cannot be adequately controlled with pre-medication
• • 14. Known allergy to stainless steel or nickel
• • 15. Contraindication to having an MRI performed (NB: Cardiac MRI subset patients only)
• • 16. Currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints
• • 17. Mean right atrial pressure higher than or equal to 15 mmHg
• 18. Patient with anomalous or abnormal CS as demonstrated by angiogram. Abnormality defined 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