NCT06951724招募中不适用
A Prospective, Multicenter, Randomized Controlled, Noninferiority Clinical Trial Evaluating the Efficacy and Safety of an Aspiration Catheter in Patients Undergoing PCI for Acute ST-Segment Elevation Myocardial Infarction (STEMI)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- The rate of TIMI flow grad 3 after PCI
研究概览
简要总结
To evaluation of the efficacy and safety of an aspiration catheter in patients undergoing PCI for acute ST-segment elevation myocardial infarction (STEMI).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General inclusion criteria
- •Age 18-80 years old (inclusive);
- •Clinical diagnosis of acute ST-segment elevation myocardial infarction (STEMI) within 24 hours of the onset of the disease (where ST-segment elevation is defined as ST-segment elevation of ≥1mm or 0.1mV in 2 or more consecutive leads of the 12-lead ECG);
- •Voluntary participation and signed written informed consent. Imaging Inclusion Criteria
- •DSA image showed that the target lesion was in situ coronary artery lesion;
- •Target vessel TIMI thrombus load classification ≥ grade 3 and TIMI flow classification ≤ grade 1;
排除标准
- •General exclusion criteria
- •previous PCI intervention or coronary artery bypass grafting (CABG) in the target vessel;
- •Comorbid cardiogenic shock;
- •severe renal failure or ongoing dialysis;
- •severe coagulation abnormalities (e.g., hypercoagulability due to blood disorders);
- •Failure of preoperative thrombolysis requiring remedial PCI;
- •Serious bleeding events requiring transfusion therapy within 30 days prior to surgery;
- •Ischemic stroke within 3 months prior to surgery;
- •Known allergy to anticoagulant and antiplatelet agents or contrast media;
- •female subjects who are known to be pregnant or lactating;
- •Participation or planned participation in other clinical studies of drugs or devices;
- •other conditions that the investigator evaluates to be unsuitable for participation in this trial.
- •Imaging exclusion criteria
- •Prognostic aspiration catheter needs to pass through the original stent mesh to reach the thrombus aspiration site;
- •severe calcification or tortuosity of the target vessel or extreme angulation that would interfere with the passage of the suction catheter;
- •the presence of an unprotected left main lesion (more than 50% narrowing of the lumen diameter);
- •the presence of severe triple coronary artery lesions requiring revascularization.
结局指标
主要结局
The rate of TIMI flow grad 3 after PCI
时间窗: Immediately after procedure
Defined as the percentage of subjects with TIMI flow graded 3 after PCI.
次要结局
- AE and SAE(30-day follow-up after procedure)
- TIMI Thrombus Grade(Immediately after procedure)
- MACE(30-day follow-up after procedure)
- TIMI flow after PCI(Immediately after procedure)
- MBG(Immediately after procedure)
- STR(ST-segment resolution) at 90 minutes(Day 0)
- Thrombus aspiration time and number of aspirations(Immediately after procedure)
- Device technical success rate(Immediately after procedure)
研究者
研究点 (1)
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