Thrombus Aspiration in STEMI Patients With High Thrombus Burden

Study Overview
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Brief Summary
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This is a prospective, multicenter, open-label, randomized, controlled, parallel group study, in which ST-segment Elevation Myocardial Infarction (STEMI) patients with high thrombus burden(TIMI thrombus grade ≥3) are included. Patients are randomized to be treated with or without manual thrombus aspiration(TA) during primary percutaneous coronary intervention(PPCI) by a ratio of 1:1.

Detailed Description
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This study is intended to explore the efficacy of thrombus aspiration (TA) in ST-Segment Elevation Myocardial Infarction (STEMI) patients with high thrombus burden who received primary PCI within 12 hours after the onset of symptoms, reducing the incidence of cardiovascular death, recurrent myocardial infarction, stent thrombosis, target vessel revascularization within 180 days or stroke in 30 days.

Official Title
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Thrombus Aspiration in Primary Percutaneous Coronary Intervention for STEMI Patients With High Thrombus Burden

Conditions
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ST-segment Elevation Myocardial Infarction (STEMI)

Intervention / Treatment
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* Procedure: Thrombus aspiration
* Procedure: PCI Alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years; STEMI patients undergoing primary PCI within 12 hours after the onset of symptoms; High thrombus burden after guidewire passes the lesion (TIMI thrombus grade ≥3); Informed consent must be voluntary; Exclusion Criteria: Haemodynamic instability or cardiogenic shock; After thrombolytic therapy; The predicted survival time is less than 6 months due to non-cardiac disease; History of coronary artery bypass grafting; Participate in other researches within 30 days; Preoperative gastrointestinal bleeding or contraindications to dual antiplatelet therapy; Patients were considered unsuitable by other researchers.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thrombus aspiration<br>Upfront manual thrombus aspiration followed by PCI | Procedure: Thrombus aspiration<br>* Percutaneous Coronary Intervention with manual aspiration thrombectomy<br>|
| Active Comparator: PCI Alone<br>PCI without upfront manual thrombus aspiration | Procedure: PCI Alone<br>* Percutaneous Coronary Intervention without manual aspiration thrombectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiovascular events | The first occurrence of cardiovascular death, recurrent myocardial infarction, stent thrombosis or target vessel revascularization | up to180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke | The symptoms continuing for more than 24 hours or leading to death with no apparent cause other than vascular | up to 30 days | 
| Composite adverse cardiocerebrovascular events | The first occurence of cardiovascular death, recurrent myocardial infarction, stent thrombosis, target vessel revascularization or stroke. | up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thrombus Aspiration, Coronary Intervention, Thrombus Burden, ST-segment Elevation Myocardial Infarction