REDUCER-I: An Observational Study of the Neovasc Reducer™ System
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
- 试验地点
- 50
- 主要终点
- Reduction in Canadian Cardiovascular Society (CCS) Grade
研究概览
简要总结
The purpose of this study is to collect long term data of the Reducer System in subjects with refractory angina pectoris.
详细描述
This study is a multicenter, multi-country three-arm prospective and retrospective investigation in up to 400 subjects conducted at a maximum of 40 investigational centers. Arm 1 will include eligible prospective subjects. Arm 2 will include subjects who were previously enrolled and treated with the Reducer during the COSIRA (Coronary Sinus Reducer for Treatment of Refractory Angina) study. Arm 3 will include subjects who received a Reducer under CE Mark (unrelated to the COSIRA study).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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 obstructive pulmonary disease (COPD) as indicated by a forced expiratory volume in one second that is less than 55% of the predicted value
- •Subject cannot undergo exercise tolerance test
- •Subject cannot undergo 6-minute walk test
- •Severe valvular heart disease
- •Subject with pacemaker electrode in the coronary sinus (CS)
- •Subject with recent placement of a new pacemaker or defibrillator electrode in the right atrium within 3 months prior to enrollment.
- •Subject having undergone tricuspid valve replacement or repair
- •Chronic renal failure (serum creatinine >2 mg/dL), including subjects on chronic hemodialysis
- •Moribund subjects, or subjects with comorbidities limiting life expectancy to less than one year
- •Known severe reaction to required procedural medications
- •Known allergy to stainless steel or nickel
- •Magnetic Resonance Imaging (MRI) planned within 8 weeks after Reducer implantation
- •Currently enrolled in another device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints
- •Angiographic Exclusion:
- •Mean right atrial pressure greater than 15mmHg
- •Subject with anomalous or abnormal CS anatomy (e.g., tortuosity, aberrant branch, persistent left superior vena cava [SVC])
- •CS diameter at the site of planned Reducer implantation less than 9.5 mm or greater than 13 mm
结局指标
主要结局
Reduction in Canadian Cardiovascular Society (CCS) Grade
时间窗: 6 Months
The percentage of subjects who experience improvement in their angina symptoms defined as a reduction in CCS grade, at 6 months as compared to baseline
Rate of Occurrence of Device and/or Procedure Related Peri-Procedural Serious Adverse Events (SAE)s
时间窗: 30 days post implant
The rate of occurrence of device and / or procedure-related periprocedural SAEs defined as a composite of death, Myocardial Infarction (MI), cardiac tamponade, clinically-driven re-dilation of a Reducer, life-threatening arrhythmias (Ventricular Tachycardia (VT) or Ventricular Fibrillation (VF)), and respiratory failure through 30 days post-implant
Occurrence of Major Adverse Cardiac Events (MACE)
时间窗: 30 days post implant
Major Adverse Cardiac Events (MACE): a composite of cardiac death, major stroke, and MI through 30-days post-implant
次要结局
- Reduction in Canadian Cardiovascular Society (CCS) Grade(12 months and annually through 5 years)
- Occurrence of Major Adverse Cardiac Events (MACE)(6 months, 12 months, and annually through 5 years)