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Manual Thrombus Aspiration During PCI in STEMI With Angiographically Evident Thrombus

Sponsor: Shenghua Zhou • ClinicalTrials.gov ID: NCT06654453

Registry updated: 2026-09-09

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Description

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.

Interventions

Manual thrombus aspiration (Procedure)
Manual aspiration is performed after guidewire passage and before balloon dilatation or stent implantation in the culprit coronary artery. A large-lumen aspiration catheter is connected to a syringe to generate negative pressure and remove visible thrombotic material. The operator selects the catheter configuration and determines the number of aspiration passes and when to discontinue aspiration according to coronary anatomy, residual thrombus, technical feasibility, and participant safety. Operators receive standardized device-specific training before participating in the trial. No other thrombectomy device is permitted.
Percutaneous Coronary Intervention (Procedure)
PCI is performed according to contemporary guideline-directed care and local practice. Balloon dilatation, stent implantation, vascular access, antiplatelet treatment, procedural anticoagulation, intracoronary medication, and other procedural details are determined by the operator.

Eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Conditions

ST-segment Elevation Myocardial Infarction

Locations

Department of Cardiology, The Second Xiangya Hospital of Central South University — Changsha, Hunan, China

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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