Efficacy of Thromboaspiration in Patients With High Thrombotic Burden Undergoing Primary Percutaneous Coronary Intervention
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 208
- 主要终点
- Rate of Complete ST-segment Elevation Resolution at 60 Minutes After the End of the Procedure
研究概览
简要总结
200 consecutive patients presenting with STEMI within 12 hours from the onset of symptoms and having a high thrombotic burden at coronary angiography, defined as the presence of a thrombus size ≥ 2 times the diameter of the vessel, according to a visual estimate. The main objective of the study is to evaluate the effectiveness of thrombectomy (either rheolytic or manual aspiration) as an adjunct to primary or rescue angioplasty, in patients with angiographic evidence high thrombotic burden in the culprit artery. Primary end points: (1) rate of complete ST-segment elevation resolution at 60 minutes after the end of the procedure; (2) infarct size as assessed by delayed-enhancement cardiac magnetic resonance imaging (DE-MRI) at 3 months after the index procedure.
Secondary endpoints: post-procedural TIMI flow grade; post-procedural MBG; infarct transmurality at 3 months; MVO at 3 months; 1-year actuarial freedom from MACEs.
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prolonged, continuous signs and symptoms of ischemia lasting more than 20 min, starting within 12 hours prior to randomization, and ST elevation ≥ 2mm in ≥2 contiguous ECG leads, or new left bundle branch block (LBBB)
- •Presence of high thrombotic burden in the culprit lesion at diagnostic angiography (defined as the presence of a thrombus size ≥ 2 times the diameter of the vessel, according to a visual estimate, or abrupt cut-off occlusion of a coronary artery ≥3 mm in reference vessel diameter)
- •Written informed consent
排除标准
- •Low-risk (ST elevation in ≤2 leads) inferior AMI
- •Previous infarction in the same area (assessed by ECG)
- •PCI in the 2 weeks prior to AMI
- •Active internal bleeding
- •History of cerebrovascular accident in the previous 2 years or cerebrovascular accident with a significant residual neurological deficit
- •Head or spine surgery or trauma in the previous 2 months
- •Recent (within six weeks) gastrointestinal (GI) or genitourinary (GU) bleeding of clinical significance
- •Administration of oral anticoagulants within seven days unless prothrombin time is <1.2 times control
- •Bleeding diathesis or severe uncontrolled arterial hypertension
- •Thrombocytopenia (<100 000 cells/mL)
- •Recent (within six weeks) major surgery or trauma
- •Intracranial neoplasm, arteriovenous malformation, or aneurysm
- •Severe renal or liver failure
- •Allergy to aspirin
- •Contraindication to MRI examination
- •Pregnancy and lactation
研究组 & 干预措施
coronary thrombectomy
干预措施: coronary thrombectomy (Device)
standard primary coronary intervention
干预措施: standard primary PCI (with stenting, as required) (Device)
结局指标
主要结局
Rate of Complete ST-segment Elevation Resolution at 60 Minutes After the End of the Procedure
时间窗: 60 minutes after the end of the procedure
Infarct Size as Assessed by Delayed-enhancement Cardiac Magnetic Resonance Imaging (DE-MRI)
时间窗: 3 months after the index procedure
次要结局
未报告次要终点
研究者
Prof. Anna Sonia Petronio
Head of Cardiac Catheterization Laboratory, University of Pisa, Azienda Ospedaliero-Universitaria Pisana
University of Pisa