Percutaneous Coronary Intervention With or Without Manual Thrombus Aspiration in Patients With ST-Segment Elevation Myocardial Infarction and Angiographically Evident Thrombus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,500
- 试验地点
- 1
- 主要终点
- 30-day Major Adverse Cardiovascular Events (MACE)
研究概览
简要总结
The goal of this clinical trial is to determine whether manually removing a visible blood clot before percutaneous coronary intervention (PCI) improves outcomes in patients with ST-segment elevation myocardial infarction (STEMI). About 3500 patients who present within 24 hours of symptom onset and have angiographically evident thrombus in the culprit coronary artery (TIMI thrombus grade 2 or higher) will be randomly assigned in a 1:1 ratio to manual thrombus aspiration followed by PCI or PCI alone.
The main question is whether adding manual thrombus aspiration reduces the first major adverse cardiac or cerebrovascular event within 30 days. This composite includes death from any cause, recurrent myocardial infarction, stroke, rehospitalization for heart failure, or clinically indicated target-vessel revascularization.
Researchers will also compare coronary and myocardial reperfusion after PCI, individual clinical events, stroke and other safety outcomes, and major adverse cardiac or cerebrovascular events through 6 and 12 months. Participants will receive their assigned PCI strategy and will be followed during the index hospitalization and at 30 days, 6 months, and 12 months.
详细描述
TAPSET is an investigator-initiated, prospective, multicenter, randomized, open-label, parallel-group superiority trial with blinded endpoint assessment. Consecutive patients with STEMI presenting within 24 hours of symptom onset undergo preliminary screening and provide written informed consent before randomization. Final eligibility is confirmed after diagnostic coronary angiography demonstrates TIMI thrombus grade 2 or higher in the culprit vessel before guidewire crossing or another intervention that could alter thrombus burden.
Eligible participants are randomized through a central web-based system, stratified by six coordinating-center networks, to manual aspiration with the Sniffer II thrombus aspiration catheter followed by PCI or PCI alone. Bailout aspiration with Sniffer II is permitted in the PCI-alone group when clinically necessary. Other thrombectomy devices are not permitted. Concomitant PCI techniques and pharmacological rescue treatment are determined by the operator according to contemporary care.
The primary endpoint is the first MACCE through day 30. Clinical events are independently adjudicated, and angiographic and electrocardiographic reperfusion outcomes are centrally assessed by reviewers blinded to treatment allocation. Follow-up occurs at 30 days, 6 months, and 12 months.
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
Participants, treating operators, and clinical care teams are aware of treatment allocation. The Clinical Event Committee, central angiographic and electrocardiographic assessors, and statistical analysts remain blinded to randomized allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed ST-segment elevation myocardial infarction with symptom onset-to-hospital arrival of 24 hours or less.
- •Angiographically evident thrombus in the culprit vessel, defined as TIMI thrombus grade 2 or higher before guidewire crossing or any intervention that could alter thrombus burden.
- •Written informed consent obtained from the participant or a legally authorized representative before randomization.
排除标准
- •Cardiogenic shock, defined as persistent systolic blood pressure below 90 mmHg for at least 30 minutes or a need for vasopressor support to maintain systolic blood pressure of at least 90 mmHg, together with evidence of end-organ hypoperfusion.
- •Requirement for emergency coronary artery bypass grafting.
- •A serious noncardiovascular condition associated with an expected survival of less than 6 months.
- •Inability to obtain written informed consent from the participant or a legally authorized representative.
研究组 & 干预措施
Manual Thrombus Aspiration + PCI
Participants undergo manual aspiration of angiographically evident thrombus in the culprit coronary artery using the Sniffer II thrombus aspiration catheter, followed by PCI.
干预措施: Manual thrombus aspiration (Procedure)
Manual Thrombus Aspiration + PCI
Participants undergo manual aspiration of angiographically evident thrombus in the culprit coronary artery using the Sniffer II thrombus aspiration catheter, followed by PCI.
干预措施: Percutaneous Coronary Intervention (Procedure)
PCI Alone
Participants undergo PCI without planned thrombus aspiration.
干预措施: Percutaneous Coronary Intervention (Procedure)
结局指标
主要结局
30-day Major Adverse Cardiovascular Events (MACE)
时间窗: From enrollment to the end of treatment at 4 weeks
A composite of cardiovascular death, recurrent myocardial infarction, stroke, and rehospitalization for heart failure within 30 days post-intervention.
Major Adverse Cardiac or Cerebrovascular Events (MACCE) Within 30 Days
时间窗: From randomization through 30 days
The proportion of participants experiencing at least one of the following events: all-cause death, recurrent myocardial infarction, stroke, rehospitalization for heart failure, or clinically indicated target-vessel revascularization. Each component will also be reported separately.
次要结局
- Reperfusion Success(Within 30 minutes post-PCI (Percutaneous Coronary Intervention))
- Follow-up MACE at 6 Months(From enrollment to the end of treatment at 6 months)
- Follow-up all-cause mortality at 6 Months(From enrollment to the end of treatment at 6 months)
- Follow-up MACE at 12 Months(From enrollment to the end of treatment at 12 months)
- Follow-up all-cause mortality at 12 Months(From enrollment to the end of treatment at 12 months)
- Final TIMI Flow Grade 3(At the end of the index PCI procedure)
- Myocardial Blush Grade 3(At the end of the index PCI procedure)
- Complete ST-Segment Resolution(After PCI during the index hospitalization)
- Any Stroke Through 30 Days(From randomization through 30 days)
- Major Adverse Cardiac or Cerebrovascular Events Through 6 Months(From randomization through 6 months)
- Major Adverse Cardiac or Cerebrovascular Events Through 12 Months(From randomization through 12 months)
- Cardiovascular Death(From randomization through 6 months and through 12 months)
- All-Cause Death(From randomization through 6 months and through 12 months)
研究者
Shenghua Zhou
Director
Second Xiangya Hospital of Central South University