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Coronary Sinus Reducer for Treatment of Refractory Angina - COSIRA (COSIRA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01205893
Recruitment Status : Completed
First Posted : September 21, 2010
Last Update Posted : November 25, 2013
Sponsor:
Information provided by (Responsible Party):
Neovasc Inc.

Study Description
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Brief Summary:
The purpose of this study is to determine if the Reducer is safe and effective in treating the symptoms of refractory angina in patients that suffer from refractory angina who demonstrate reversible ischemia.

Condition or disease Intervention/treatment Phase
Refractory Angina Device: Neovasc Reducer Device: Control Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study to Confirm the Safety and Efficacy of the Reducer on Patients With Refractory Angina
Study Start Date : September 2010
Actual Primary Completion Date : October 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina

Arms and Interventions
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Arm Intervention/treatment
Experimental: Reducer
Implant Reducer
 Device: Neovasc Reducer
Implantation of the Reducer
Sham Comparator: Control
No treatment
 Device: Control
Control - No device implanted


Outcome Measures
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Primary Outcome Measures :
  1. Canadian Cardiovascular Society Angina Score [ Time Frame: 6 months ]
    A decrease of two or more Canadian Cardiovascular Society Angina Score grades from baseline to six-month post-procedural evaluation in Reducer and Control groups


Secondary Outcome Measures :
  1. Technical success [ Time Frame: 24 hours ]
    Successful delivery and deployment of the Reducer to the intended site as assessed by the investigator

  2. Procedural success [ Time Frame: 24 hours ]
    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

  3. Periprocedural Serious Adverse Event: [ Time Frame: 30 days ]
    A composite of death, myocardial infarction, cardiac tamponade, clinically-driven re-dilation of a failed Reducer, life-threatening arrhythmia, and respiratory failure through 30 days post-procedure in the Reducer group.

  4. Periprocedural Serious Adverse Event [ Time Frame: 30 days ]
    A composite of death, myocardial infarction, cardiac tamponade, life-threatening arrhythmia, and respiratory failure through 30 days post-procedure in the control group.

  5. Major Adverse Events [ Time Frame: 6 months ]
    A composite of cardiac death, major stroke, and myocardial infarction in the Reducer and Control groups through hospital discharge, and at six-month post-procedural evaluations.

  6. Canadian Cardiovascular Society Angina Score [ Time Frame: 6 months ]
    A decrease one or more Canadian Cardiovascular Society Angina Score grades from baseline to six-month post-procedural evaluation in Reducer and Control groups

  7. Dobutamine Echo Wall Motion Score Index [ Time Frame: 6 months ]
    Wall motion score index in both the Reducer and control groups at baseline and six-month post-procedural evaluation

  8. Seattle Angina Questionnaire Score [ Time Frame: 6 months ]
    Seattle Angina Questionnaire in the Reducer and Control groups at baseline and six-month post-procedural evaluation

  9. Exercise Tolerance Testing [ Time Frame: 6 months ]
    Exercise Tolerance Testing in the Reducer and Control groups at baseline and six-month post-procedural evaluation


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01205893


Locations
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Belgium
ZNA Middelheim Hospital
Antwerpen, Belgium, 2020
Ziekenhuis Oost-Limburg
Genk, Belgium, 3600
Canada, Ontario
Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Denmark
Rigshospitalet
Copenhagen, Denmark, DK-2100
Netherlands
UMC Utrecht
Utrecht, Netherlands, 3584
Sweden
Central Hospital Kristianstad
Kristianstad, Sweden, 85
United Kingdom
Royal Infirmary of Bradford
Bradford, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom, EH16 4SA
King College Hospital
London, United Kingdom, SE5 9RS
Royal Brompton Hospital
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
Neovasc Inc.
Investigators
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Principal Investigator: Stefan Verheye, MD ZNA Middelheim Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Neovasc Inc.
ClinicalTrials.gov Identifier: NCT01205893    
Other Study ID Numbers: #REDCLN-178
First Posted: September 21, 2010    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
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Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
 Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations