The purpose of this study is to implant the Reducer in patients with the symptoms of refractory angina, that suffer from refractory angina who demonstrate reversible ischemia.
>18 years old
Symptomatic CAD with chronic refractory angina pectoris classified as Canadian Cardiovascular Society (CCS) grade III or IV despite attempted optimal medical therapy for thirty days prior to screening
Non-candidate for surgical or percutaneous coronary intervention, as determined by 2 independent Professors of Internal medicine
Reversible ischemia of the left ventricular wall demonstrated by Dobutamine Stress Echocardiography (Dobutamine ECHO; DSE), or by Thallium Spect
Recent (within three months) acute coronary syndrome
Recent (within six months) 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 or hospitalization due to CHF during the three months prior to screening
Single group
Neovac coronary sinus reducer
Devicereducer
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
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Tel-Aviv Sourasky Medical Center
Lead sponsor
Shockwave Medical, Inc.
Collaborator
