NCT01205893CompletedPhase 2
Study to Confirm the Safety and Efficacy of the Reducer on Patients With Refractory Angina
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Neovasc Inc.
- Enrollment
- 104
- Locations
- 11
- Primary Endpoint
- Canadian Cardiovascular Society Angina Score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient is older than 18 years of age
- •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
- •Patient has limited treatment options for revascularization by coronary artery bypass grafting or by percutaneous coronary intervention
- •Evidence of reversible ischemia that is attributable to the left coronary arterial system by Dobutamine Echo
- •Left ventricular ejection fraction greater than 25%
- •Male or non-pregnant female (NB: Females of child bearing potential must have a negative pregnancy test)
- •Patient understands the nature of the procedure and provides written informed consent prior to enrollment
- •Patient is willing to comply with specified follow-up evaluation and can be contacted by telephone
Exclusion Criteria
- •Recent (within three months) acute coronary syndrome
- •Recent (within six months) successful PCI or CABG
- •Unstable angina (recent onset angina, crescendo angina, or rest angina with ECG changes) during the thirty days prior to screening
- •De-compensated congestive heart failure (CHF) or hospitalization due to CHF during the three months prior to screening
- •Life threatening rhythm disorders or any rhythm disorders that would require placement of an internal defibrillator and or pacemaker
- •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
- •Patient cannot undergo exercise tolerance test (bicycle) for reasons other than refractory angina
- •Severe valvular heart disease
- •Patient with pacemaker or defibrillator electrode in the right atrium, right ventricle, or coronary sinus
- •Patient having undergone tricuspid valve replacement or repair
- •Chronic renal failure (serum creatinine >2 mg/dL), including patients on chronic hemodialysis
- •Moribund patients, or patients with comorbidities limiting life expectancy to less than one year
- •Contraindication to required study medications that cannot be adequately controlled with pre-medication
- •Known allergy to stainless steel or nickel
- •Contraindication to having an MRI performed (NB: Cardiac MRI subset patients only)
- •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
- •Mean right atrial pressure higher than or equal to 15 mmHg
- •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
Arms & Interventions
Reducer
Experimental
Implant Reducer
Intervention: Neovasc Reducer (Device)
Control
Sham Comparator
No treatment
Intervention: Control (Device)
Outcomes
Primary Outcomes
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 Outcomes
- Procedural success(24 hours)
- Periprocedural Serious Adverse Event:(30 days)
- Periprocedural Serious Adverse Event(30 days)
- Major Adverse Events(6 months)
- Canadian Cardiovascular Society Angina Score(6 months)
- Dobutamine Echo Wall Motion Score Index(6 months)
- Seattle Angina Questionnaire Score(6 months)
- Exercise Tolerance Testing(6 months)
- Technical success(24 hours)
Investigators
Study Sites (11)
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