Observational Registry to Evaluate Real World Usage of PiCSO Impulse System in STEMI Patients as Part of Post-marketing Surveillance
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Adverse Device Effect (ADE) rate at 30 days post index procedure PCI
研究概览
简要总结
A prospective, multicenter, single-arm, open label registry of commercially treated patients with PiCSO Impulse System.
详细描述
This is a observational registry study. Patients with an ST-segment elevated anterior infarct eligible for PCI and commercial PiCSO treatment will be invited to participate in the PiCSO-AMI-IV study. After having given consent as per approved ethics committee requirements, the PCI of the culprit vessel should be performed per standard practices. After blood flow restoration, the coronary sinus (CS) will be cannulated through the femoral vein and the PiCSO Impulse Catheter will be placed in the CS to start the PiCSO therapy. After the procedure the patient will be followed for safety assessments at 30 days, 6 months, 1 year, 2 year and 3 years post index procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •ST-segment elevation
- •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.
- •Patient is deemed eligible for PCI
- •Consent as per approved national ethical committee specific requirements prior to the procedure.
排除标准
- •Patients with contraindications to percutaneous insertion or angiography
- •Patients with implants or foreign bodies in the coronary sinus
- •Known allergy to polyurethanes, PET or stainless steel
- •Known pregnancy or breast feeding
- •Known pericardial effusion or cardiac tamponade
- •Known central hemodynamically relevant left/right shunt
- •Patients with symptom onset > 12 hours
- •Patients with previous CABG
- •Patients with a history of stroke, TIA or reversible ischemic neurological deficit within last 6 month.
- •Patients with coagulopathy
- •Patients under judicial protection, legal guardianship or curatorship.
结局指标
主要结局
Adverse Device Effect (ADE) rate at 30 days post index procedure PCI
时间窗: 30 days
Adverse Device Effect (ADE) rate at 30 days post index procedure PCI
次要结局
未报告次要终点