NCT01493037已完成不适用
Pressure Controlled Intermittent Coronary Sinus Occlusion in Patients With ST Segment Elevation Myocardial Infarction Treated by Primary Percutaneous Coronary Intervention: Safety and Feasibility Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Successful delivery of PICSO treatment
研究概览
简要总结
A prospective multi-center study in which patients with an acute heart attack (in the left anterior descending artery) with ECG changes (ST segment elevation) receive angioplasty followed by stent placement and 90 minutes of PICSO treatment. This is a proof of concept study designed to document the safety and feasibility of the Pressure Controlled Intermittent Coronary Sinus Occlusion (PICSO) Impulse system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •First time anterior STEMI defined by the following:
- •Symptoms of myocardial ischemia > 30 minutes and < 12 hours
- •ST-segment elevation > 1mm (> 0.1 mV) in two contiguous precordial leads in the anterior territory on a 12-lead ECG
- •Uncomplicated PCI of a LAD culprit lesion (defined as angioplasty followed by stent placement or direct stenting without the occurrence of an adverse event(s) that would preclude further study participation, such as major bleeding, perforation, hypotension, pulmonary edema or instability that in the judgement of the investigator preclude participation in the trial)
排除标准
- •Younger than 18 years of age
- •Hospitalization with a primary diagnosis of acute myocardial infarction (AMI) previously or has evidence of previous Q-wave infarct
- •Left main coronary artery culprit lesion
- •Additional stenosis in the LAD for which PCI or CABG is likely to be needed in the next 6 months and which is not treated during the index procedure
- •Cardiogenic shock (systolic blood pressure ≤90 mmHg in spite of conservative measures) or pulmonary edema (O2 saturation <90% by pulse oximetry and the presence of rales or crackles)
- •Cardiac arrest requiring chest compression or resuscitation
- •Anatomical complications limit capacity to place PICSO Impulse device or achieve stable catheter placement or occlude coronary sinus
- •Known renal disease (GFR < 30 mL/min/1.73m2) or dialysis
- •History of stroke, TIA or reversible ischemic neurological disease within last 6 months
- •Left bundle branch block
- •Known contra-indication for magnetic resonance imaging (Metallic implant precluding MRI, claustrophobia, obesity precluding MRI, etc.)
- •Presence of any lead in the coronary sinus
- •Active or treated malignancies in the last 12 months
- •Previous coronary artery bypass graft surgery
- •Known severe anemia (Hgb < 10 g/dL or < 6.2 mmol/L)
- •Known platelet count < 100,000, known coagulopathy or bleeding diathesis, or unwilling to accept transfusions
- •Participation in another ongoing clinical study
- •Women of child-bearing age
- •Non-cardiac comorbidities and life expectancy < 1 year
- •Legal incompetence
- •A condition that, in the opinion of the Investigator, precludes participation, including compliance with all follow-up procedures
- •No dependents neither to the sponsor nor to the investigator
结局指标
主要结局
Successful delivery of PICSO treatment
时间窗: 90 minutes
Assessment of the feasibiity of PICSO in STEMI patients defined as the successful elivery of the PICSO catheter and the successful administration of PICSO treatment for 90 minutes
次要结局
- MRI measurement of infarct size(4 months)
- Assessment of left ventricular function(4 months)
- Assessment of microvascular perfusion(4 months)
- Resolution of ST-segment elevation(24 hours)
- Measurement of ST segment time curve area(3 hours)
- Number of adverse events(6 months)
研究者
研究点 (3)
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