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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
104
Implantation of the Reducer
Control - No device implanted
ZNA Middelheim Hospital
Antwerp, Belgium
Ziekenhuis Oost-Limburg
Genk, Belgium
Ottawa Heart Institute
Ottawa, Ontario, Canada
Montreal Heart Institute
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
Time frame: 6 months
Technical success
Successful delivery and deployment of the Reducer to the intended site as assessed by the investigator
Time frame: 24 hours
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
Time frame: 24 hours
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.
Time frame: 30 days
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.
Time frame: 30 days
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.
Time frame: 6 months
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
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Montreal, Quebec, Canada
Rigshospitalet
Copenhagen, Denmark
UMC Utrecht
Utrecht, Netherlands
Central Hospital Kristianstad
Kristianstad, Sweden
Royal Infirmary of Bradford
Bradford, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom
King College Hospital
London, United Kingdom
...and 1 more locations
Time frame: 6 months
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
Time frame: 6 months
Seattle Angina Questionnaire Score
Seattle Angina Questionnaire in the Reducer and Control groups at baseline and six-month post-procedural evaluation
Time frame: 6 months
Exercise Tolerance Testing
Exercise Tolerance Testing in the Reducer and Control groups at baseline and six-month post-procedural evaluation
Time frame: 6 months