COSIRA - COronary SInus Reducer* for Treatment of Refractory Angina

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

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

- 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>CCS Angina Pectoris Classification: a decrease in two or more CCS angina<br /><br>pectoris grades from baseline to six-month post-procedural evaluation in<br /><br>Reducer and Control groups</p><br>

Secondary Outcome Measures