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Table 1 Inclusion and exclusion criteria for COSIRA

From: A phase II, sham-controlled, double-blinded study testing the safety and efficacy of the coronary sinus reducer in patients with refractory angina: study protocol for a randomized controlled trial

A. Inclusion criteria

B. Exclusion criteria

1. Patient >18 years of age

Clinical

2. Symptomatic CAD with chronic refractory angina pectoris classified as CCS class III or IV despite attempted optimal medical therapy for 30 days prior to screening

1. Recent (<3 months) acute coronary syndrome

3. Patient has limited treatment options for revascularization by CABG or PCI

2. Recent (<6 months) successful PCI or CABG

4. Evidence of reversible ischemia that is attributable to the left coronary arterial system by dobutamine echocardiography

3. Recent (<1 month) unstable angina (recent onset, crescendo, or rest angina with ECG changes)

5. Left ventricular ejection fraction >25%

4. De-compensated CHF or hospitalization due to CHF during the 3 months prior to screening

6. Male or nonpregnant female (NB: Females of child-bearing potential must have a negative pregnancy test)

5. Patient with pacemaker or defibrillator electrode in the right atrium, right ventricle, or coronary sinus

7. Patient understands the nature of the procedure and provides written informed consent prior to enrollment

6. Life-threatening rhythm disorders or any rhythm disorders requiring an internal defibrillator and or pacemaker

8. Patient is willing to comply with specified follow-up evaluation and can be contacted by telephone

7. Severe COPD as indicated by a forced expiratory volume in one second <55% of the predicted value

 

8. Patient cannot undergo exercise tolerance test (bicycle) for reasons other than refractory angina

 

9. Severe valvular heart disease

 

10. Patient having undergone tricuspid valve replacement or repair

 

11. Chronic renal failure (serum creatinine >2 mg/dL), including patients on chronic hemodyalisis

 

12. Moribund patients, or patients with comorbidities limiting life expectancy <1 year

 

13. Contraindication to required study medications that cannot be adequately controlled with premedication

 

14. Known allergy to stainless steel or nickel

 

15. 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

 

Anatomical

 

16. Mean right atrial pressure ≥_ 15 mmHg

 

17. Patient with anomalous or abnormal CS as demonstrated by angiographic abnormalities defined either:

 

 a. Abnormal CS anatomy (for example, tortuosity, aberrant branch, persistent left SVC) and/or;

 

 b. CS diameter at the site of planned Reducer implantation <9.5 mm or >13 mm

  1. CABG coronary artery bypass graft; CAD coronary artery disease; CCS Canadian Cardiovascular Society; CHF congestive heart failure; COPD chronic obstructive pulmonary disease; CS coronary sinus; ECG electrocardiogram; PCI percutaneous coronary intervention; SVC superior vena cava.