Manual Thrombus Aspiration During PCI in STEMI With Angiographically Evident Thrombus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorShenghua Zhou
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Manual thrombus aspiration
Procedure/SurgeryManual 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/SurgeryPCI 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.
Treatment groups
3,500 Participants
are divided into 2 treatment groupsGroup A: Manual Thrombus Aspiration + PCIExperimental treatment 2 interventions
Group B: PCI AloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Major Adverse Cardiac or Cerebrovascular Events (MACCE) Within 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.
Time frame
From randomization through 30 daysSecondary outcomes
1
Final TIMI Flow Grade 3
The proportion of participants with final Thrombolysis in Myocardial Infarction (TIMI) epicardial coronary flow grade 3, assessed by the blinded central angiographic assessment team.
Time frame
At the end of the index PCI procedure2
Myocardial Blush Grade 3
The proportion of participants with myocardial blush grade 3, assessed by the blinded central angiographic assessment team. The full myocardial blush grade 0-3 distribution will also be reported.
Time frame
At the end of the index PCI procedure3
Complete ST-Segment Resolution
The proportion of participants with at least 70% ST-segment resolution from the pre-PCI to the post-PCI electrocardiogram, assessed by the blinded central electrocardiographic assessment team.
Time frame
After PCI during the index hospitalization4
Any Stroke Through 30 Days
The proportion of participants experiencing any adjudicated stroke.
Time frame
From randomization through 30 daysOther outcomes
1
Additional Adjudicated Safety Events
The occurrence of transient ischemic attack, Bleeding Academic Research Consortium type 3 or 5 bleeding, and definite or probable stent thrombosis. Each event type will be reported separately.
Time frame
From randomization through 12 months2
Procedural and Device-Related Complications
The occurrence of coronary dissection or perforation; catheter entrapment, fracture, malfunction, or failure to retrieve; distal embolization; no-reflow; and access-site or other vascular complications. Each complication type will be reported separately.
Time frame
During the index PCI procedure and index hospitalizationSponsors and contacts
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Shenghua Zhou
Lead sponsor
Second Xiangya Hospital of Central South University
Sponsor institution
Second Xiangya Hospital of Central South University
Collaborator
The General Hospital of Northern Theater Command
Collaborator
Second Hospital of Jilin University
Collaborator
First Affiliated Hospital Xi'an Jiaotong University
Collaborator
The First Affiliated Hospital of Dalian Medical University
Collaborator
Capital Medical University
Collaborator
Source ClinicalTrials.gov