Polish-Italian-Hungarian RAndomized ThrombEctomy Trial. PIHRATE Trial.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 200
- 试验地点
- 9
- 主要终点
- ST resolution >70% 60 minutes after PCI
研究概览
简要总结
Aim Primary percutaneous coronary intervention efficacy improvement by DIVER CE thrombectomy system leading to thrombus reduction.
Study design:
Multicenter, prospective, opened, randomized.
Primary endpoints:
ST resolution >70% 60 minutes after PCI
Secondary endpoints:
Thrombectomy system efficacy/passing trough lesion with thrombus reduction according do TIMI thrombus scale ≥ 1 TIMI 3 flow after PCI MBG 3 CMR - infarct size, measurement of left ventricular end-diastolic EDV and end-systolic volumes ESV and ejection fraction (EF) ECHO: measurement of left ventricular end-diastolic EDV and end-systolic volumes ESV, ejection fraction (EF) and wall motion score index (WMSI) Major cardiac events /cardiac death, reMI, rePCI (TVR, TLR, non infarct involved vessel) or CABG/ 6 month follow up Rate of composite angiographic adverse events including: distal embolisation, transient no-reflow or slow flow, final TIMI <3, need of bail out GpIIb/IIIa inhibitors or adenosine or nitroprosside, final thrombus score >1
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ST elevation acute myocardial infarction within 6 hours since pain onset, with 2 mm ST segment elevation in two lead
- •Minimum 3 mm ST segment elevation in one leads
- •Vessel reference diameter > 2.5 mm
- •When vessel reference diameter ≥ 4,0 mm than additional distal protection device (filter) is needed during stent implantation
排除标准
- •Contraindications to PCI (contrast allergy, no possibility to stent implantation) ASA, thienopirydins or GP IIb/IIIa inhibitors
- •Active bleeding or coagutopathy
- •Prior CABG or PCI
- •Known ejection fraction EF <35%
- •Cardiogenic shock /SBP < 90 mmHg, IABP and/or catheloamins usage/
- •LBBB, pacemaker rhythm
- •Severe calcifications
- •Previous Myocardial infarction
- •Stroke history
- •Patient directly after reanimation
- •Known thrombocytopenia- platelets < 100 000
- •Pregnancy
- •Cancer disease
- •No future patient cooperation expected
- •Patient's taking part in the other clinical trials
- •Fibrynolisis directly administered before PCI
- •Renal insufficiency (creatynine > 220 µmol/ml), hemodialysis
- •Contraindications to PCI (contrast allergy, no possibility to stent implantation) ASA, thienopirydins or GP IIb/IIIa inhibitors
- •Active bleeding or coagutopathy
- •Prior CABG or PCI
- •Known ejection fraction EF <35%
- •Cardiogenic shock /SBP < 90 mmHg, IABP and/or catheloamins usage/
- •LBBB, pacemaker rhythm
- •Severe calcifications
- •Previous Myocardial infarction
- •Stroke history
- •Patient directly after reanimation
- •Known thrombocytopenia- platelets < 100 000
- •Pregnancy
- •Cancer disease
- •No future patient cooperation expected
- •Patient's taking part in the other clinical trials
- •Fibrynolisis directly administered before PCI
- •Renal insufficiency (creatynine > 220 µmol/ml), hemodialysis
- •Liver insufficiency
结局指标
主要结局
ST resolution >70% 60 minutes after PCI
次要结局
- Thrombectomy system efficacy/passing trough lesion with thrombus reduction according do TIMI thrombus scale ≥ 1
- TIMI 3 flow after PCI
- MBG 3
- CMR - infarct size, measurement of left ventricular end-diastolic EDV and end-systolic volumes ESV and ejection fraction (EF)
- ECHO: measurement of left ventricular end-diastolic EDV and end-systolic volumes ESV, ejection fraction (EF) and wall motion score index (WMSI)
- Major cardiac events /cardiac death, reMI, rePCI (TVR, TLR, non infarct involved vessel) or CABG/ 6 month follow up
- Rate of composite angiographic adverse events including: distal embolisation, transient no-reflow or slow flow, final TIMI <3, need of bail out GpIIb/IIIa inhibitors or adenosine or nitroprosside, final thrombus score >1