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Coronary Sinus Reducer for Treatment of Refractory Angina - COSIRA

Sponsor
Neovasc Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01205893
Collaborator
(none)
104
Enrollment
11
Locations
2
Arms
38
Duration (Months)
9.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Neovasc Reducer
  • Device: Control
 Phase 2

Study Design

Study Type:
Interventional
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 :
Sep 1, 2010
Actual Primary Completion Date :
Oct 1, 2013
Actual Study Completion Date :
Nov 1, 2013

Arms and Interventions

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

Primary Outcome Measures

  1. Canadian Cardiovascular Society Angina Score [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 [24 hours]

    Successful delivery and deployment of the Reducer to the intended site as assessed by the investigator

  2. Procedural success [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: [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 [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 [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 [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 [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 [6 months]

    Seattle Angina Questionnaire in the Reducer and Control groups at baseline and six-month post-procedural evaluation

  9. Exercise Tolerance Testing [6 months]

    Exercise Tolerance Testing in the Reducer and Control groups at baseline and six-month post-procedural evaluation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 ZNA Middelheim Hospital Antwerpen Belgium 2020
2 Ziekenhuis Oost-Limburg Genk Belgium 3600
3 Ottawa Heart Institute Ottawa Ontario Canada K1Y 4W7
4 Montreal Heart Institute Montreal Quebec Canada H1T 1C8
5 Rigshospitalet Copenhagen Denmark DK-2100
6 UMC Utrecht Utrecht Netherlands 3584
7 Central Hospital Kristianstad Kristianstad Sweden 85
8 Royal Infirmary of Bradford Bradford United Kingdom
9 Royal Infirmary of Edinburgh Edinburgh United Kingdom EH16 4SA
10 King College Hospital London United Kingdom SE5 9RS
11 Royal Brompton Hospital London United Kingdom SW3 6NP

Sponsors and Collaborators

  • Neovasc Inc.

Investigators

  • Principal Investigator: Stefan Verheye, MD, ZNA Middelheim Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Neovasc Inc.
ClinicalTrials.gov Identifier:
NCT01205893
Other Study ID Numbers:
  • #REDCLN-178
First Posted:
Sep 21, 2010
Last Update Posted:
Nov 25, 2013
Last Verified:
Nov 1, 2013
Additional relevant MeSH terms:
Angina Pectoris

Study Results

No Results Posted as of Nov 25, 2013