The purpose of this study is to collect long term data of the Reducer System in subjects with refractory angina pectoris.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria - ALL Arms:
* Subject has been informed about the study and provides written informed consent prior to enrollment
* Subject is willing to comply with specified follow-up evaluations
Inclusion Criteria - Arm 1:
* Symptomatic Coronary Artery Disease (CAD) with chronic refractory angina pectoris despite attempted optimal medical therapy
* Subject has limited treatment options for revascularization by Coronary Artery Bypass Grafting (CABG) or by Percutaneous Coronary Intervention (PCI)
* Evidence of reversible myocardial ischemia
* Left Ventricular ejection fraction (LVEF) greater than or equal to 30%
* Male or non-pregnant female
Inclusion Criteria - Arm 2:
* Subjects previously implanted in the Reducer (treatment) arm of the COSIRA study
Inclusion Criteria - Arm 3:
* Subjects in whom the Reducer was implanted under CE Mark (unrelated to the COSIRA study), prior to enrollment in the Reducer-I study
Exclusion Criteria - Arm 1:
* Acute coronary syndrome within three months prior to enrollment
* Recent successful revascularization by PCI or CABG within six months prior to enrollment
* Recent unsuccessful PCI (no relief from symptoms) within 30 days prior to enrollment
* Unstable angina (recent onset angina, crescendo angina, or rest angina with electrocardiogram \[ECG\] changes) during the 30 days prior to enrollment
* Decompensated congestive heart failure (CHF) or hospitalization due to CHF during the three months prior to enrollment
* Severe chronic o…
What they're measuring
1
Reduction in Canadian Cardiovascular Society (CCS) Grade
Timeframe: 6 Months
2
Rate of Occurrence of Device and/or Procedure Related Peri-Procedural Serious Adverse Events (SAE)s