First Randomized Study of Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO) in Acute Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 21
- 主要终点
- Infarct size 5 days post MI
研究概览
简要总结
The objective of this study is to assess efficacy and safety of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) therapy started post flow restoration but prior to stenting during percutaneous coronary intervention (PCI) compared to standard PCI in the setting of acute ST-segment elevation anterior myocardial infarction (STEMI).
详细描述
This is a prospective, multicenter, randomized (1:1), controlled, study. Patients with an ST-segment elevated anterior infarct eligible for PCI will be invited to participate in the PiCSO-AMI-I study. After consent as per pproved ethics committee requirements, baseline assessments will be performed. PCI of the culprit vessel should be performed per standard practices. After blood flow restoration, the subjects meeting all inclusion and none exclusion criterial will be enrolled into the study and randomized either to PiCSO Group or Control Group. If the subject is randomized to PiCSO Group, the coronary sinus (CS) will be cannulated through the femoral vein and the PiCSO Impulse Catheter will be placed in the CS. In the event the PiCSO Impulse Catheter cannot be placed in the CS within 30 minutes, the physician should proceed with the regular PCI and the PiCSO treatment will be considered a failure. Once PiCSO Impulse Catheter is placed into CS, PiCSO treatment is started followed by stenting. The physician shall target a PiCSO treatment of 45 minutes (at minimum 30 minutes) whereas the treatment should be continued during and post stent insertion, but should not exceed a maximum duration of 90 minutes. At the end of the PiCSO treatment, the PiCSO Impulse Console is stopped and the PiCSO Impulse Catheter is removed. The patient is seen for a FU visit at 5 days, 30 days, 6 months, 1 year, 2 year and 3 years post index procedure. 5 days and 6 months post index the patient will get a CMR scan. At every FU visit safety data and health status will be documented and quality of life questionnaire will be completed.
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
- Single (Outcomes Assessor)
盲法说明
Analysis of the primary endpoint, infarct size 5-days post MI assessed by CMR, will be analyzed by an independent Corelab, blinded to the allocated treatment arm.
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
- •Age ≥18 years old
- •Culprit lesion in proximal or mid LAD
- •Pre-PCI TIMI flow 0 or
- •Symptoms onset time consistent with myocardial ischemia (e.g. persistent chest pain, shortness of breath, nausea/vomiting, fatigue, palpitations or syncope) ≤ 12 h.
- •ECG evidence of acute anterior myocardial infarction with ST-elevation ≥ 2 mm (0.2 mV) in 2 or more contiguous anterior precordial ECG leads (one of which should be V2, V3, or V4) in men or ≥ 1.5 mm (0.15 mV) in women
- •Patient is deemed eligible for primary PCI
- •STEMI patients: consent as per approved national ethical committee specific requirements prior to the procedure.
- •Exclusion criteria:
- •Implants or foreign bodies in the coronary sinus
- •Known allergy to polyurethanes, PET or stainless steel
- •Known pregnancy and breastfeeding
- •Pericardial effusion (cardiac tamponade)
- •Central hemodynamically relevant left/right shunt
- •Previous MI or CABG
- •History of stroke, TIA or reversible ischemic neurological deficit within last 6 months
- •Known coagulopathy
- •Need for circulatory support or pre-procedural ventilation
- •Patients with cardio-pulmonary resuscitated (CPR) cardiac arrest for more than 5 minutes
- •Patient not suitable for femoral vein access
- •Contraindication to cardiac magnetic resonance imaging (CMR), e.g. claustrophobia, foreign body implants incompatible with CMR, gadolinium intolerance.
- •Active participation in another drug or device investigational study
- •Known severe kidney disease or on hemodialysis
- •Unconscious on presentation
- •Patients under judicial protection, legal guardianship or curatorship
排除标准
- 未提供
结局指标
主要结局
Infarct size 5 days post MI
时间窗: 5 days post MI
Difference in myocardial infarct size (extent of myocardial necrosis quantified by delayed gadolinium enhancement presented as a percentage of LV mass) between the PiCSO Group and the Control Group, assessed by CMR at 5 days post index PCI
次要结局
- Myocardial Salvage(5 days and 6 months post MI)
- LVEDV(5 days and 6 months post MI)
- ST-segment resolution(90 minutes)
- Infarct size 6 months post MI(6 months post MI)
- MVO(5 days post MI)
- LVEF(5 days and 6 months post MI)
- LVESV(5 days and 6 months post MI)
- Device and Procedural success, assessed as percent of subjects with successful access, delivery, and retrieval of the device and its delivery system(1 day)