NCT01205893已完成2 期
Study to Confirm the Safety and Efficacy of the Reducer on Patients With Refractory Angina
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Neovasc Inc.
- 入组人数
- 104
- 试验地点
- 21
- 主要终点
- Canadian Cardiovascular Society Angina Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •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
排除标准
- •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
结局指标
主要结局
Canadian Cardiovascular Society Angina Score
时间窗: 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
次要结局
- 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)
研究者
研究点 (21)
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