Coronary Sinus Reducer for Treatment of Refractory Angina - COSIRA

Refractory Angina Clinical Trial

— COSIRA  

Official title:

Study to Confirm the Safety and Efficacy of the Reducer on Patients With Refractory Angina

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01205893
• Other study ID #: #REDCLN-178
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2010
• Last updated: November 22, 2013
• Start date: September 2010
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: Neovasc Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics CommitteeBelgium: Ministry of Social Affairs, Public Health and the Environment
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: November 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina Pectoris
• Refractory Angina

Intervention

Device:
• Neovasc Reducer
Implantation of the Reducer
• Control
Control - No device implanted

Locations

Country	Name	City	State
Belgium	ZNA Middelheim Hospital	Antwerpen
Belgium	Ziekenhuis Oost-Limburg	Genk
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	Ottawa Heart Institute	Ottawa	Ontario
Denmark	Rigshospitalet	Copenhagen
Netherlands	UMC Utrecht	Utrecht
Sweden	Central Hospital Kristianstad	Kristianstad
United Kingdom	Royal Infirmary of Bradford	Bradford
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh
United Kingdom	King College Hospital	London
United Kingdom	Royal Brompton Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Neovasc Inc.

Countries where clinical trial is conducted

Belgium,  Canada,  Denmark,  Netherlands,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Canadian Cardiovascular Society Angina Score	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	6 months	No
Secondary	Technical success	Successful delivery and deployment of the Reducer to the intended site as assessed by the investigator	24 hours	Yes
Secondary	Procedural success	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	24 hours	Yes
Secondary	Periprocedural Serious Adverse Event:	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.	30 days	Yes
Secondary	Periprocedural Serious Adverse Event	A composite of death, myocardial infarction, cardiac tamponade, life-threatening arrhythmia, and respiratory failure through 30 days post-procedure in the control group.	30 days	Yes
Secondary	Major Adverse Events	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 months	Yes
Secondary	Canadian Cardiovascular Society Angina Score	A decrease one or more Canadian Cardiovascular Society Angina Score grades from baseline to six-month post-procedural evaluation in Reducer and Control groups	6 months	No
Secondary	Dobutamine Echo Wall Motion Score Index	Wall motion score index in both the Reducer and control groups at baseline and six-month post-procedural evaluation	6 months	No
Secondary	Seattle Angina Questionnaire Score	Seattle Angina Questionnaire in the Reducer and Control groups at baseline and six-month post-procedural evaluation	6 months	No
Secondary	Exercise Tolerance Testing	Exercise Tolerance Testing in the Reducer and Control groups at baseline and six-month post-procedural evaluation	6 months	No