Coronary Sinus Reducer for Treatment of Refractory Angina - COSIRA

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Neovasc Inc.
ClinicalTrials.gov Identifier:
NCT01205893
First received: September 13, 2010
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Refractory Angina
Device: Neovasc Reducer
Device: Control
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study to Confirm the Safety and Efficacy of the Reducer on Patients With Refractory Angina

Resource links provided by NLM:


Further study details as provided by Neovasc Inc.:

Primary Outcome Measures:
  • Canadian Cardiovascular Society Angina Score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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:
  • Technical success [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Successful delivery and deployment of the Reducer to the intended site as assessed by the investigator

  • Procedural success [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    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

  • Periprocedural Serious Adverse Event: [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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.

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

  • Major Adverse Events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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.

  • Canadian Cardiovascular Society Angina Score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    A decrease one or more Canadian Cardiovascular Society Angina Score grades from baseline to six-month post-procedural evaluation in Reducer and Control groups

  • Dobutamine Echo Wall Motion Score Index [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Wall motion score index in both the Reducer and control groups at baseline and six-month post-procedural evaluation

  • Seattle Angina Questionnaire Score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Seattle Angina Questionnaire in the Reducer and Control groups at baseline and six-month post-procedural evaluation

  • Exercise Tolerance Testing [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Exercise Tolerance Testing in the Reducer and Control groups at baseline and six-month post-procedural evaluation


Enrollment: 104
Study Start Date: September 2010
Study Completion Date: November 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Reducer
Implant Reducer
Device: Neovasc Reducer
Implantation of the Reducer
Sham Comparator: Control
No treatment
Device: Control
Control - No device implanted

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01205893

Locations
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
Royal Brompton Hospital
London, United Kingdom, SW3 6NP
King College Hospital
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
Neovasc Inc.
Investigators
Principal Investigator: Stefan Verheye, MD ZNA Middelheim Hospital
  More Information

No publications provided by Neovasc Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Neovasc Inc.
ClinicalTrials.gov Identifier: NCT01205893     History of Changes
Other Study ID Numbers: #REDCLN-178
Study First Received: September 13, 2010
Last Updated: November 22, 2013
Health Authority: Belgium: Ethics Committee
Belgium: Ministry of Social Affairs, Public Health and the Environment

Additional relevant MeSH terms:
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Heart Diseases
Myocardial Ischemia
Pain
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014