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NCT Number: NCT06654453

Manual Thrombus Aspiration During PCI in STEMI With Angiographically Evident Thrombus

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.

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Key information

Conditions

ST-segment Elevation Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Cardiology, The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

Location status: Recruiting

Location contact

Shenghua Zhou, MD

CONTACT

[email protected]

+86-731-85292012

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Major Adverse Cardiac or Cerebrovascular Events (MACCE) Within 30 Days

    Time frame: 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.

Secondary outcomes

  1. Final TIMI Flow Grade 3

    Time frame: At the end of the index PCI procedure

    The proportion of participants with final Thrombolysis in Myocardial Infarction (TIMI) epicardial coronary flow grade 3, assessed by the blinded central angiographic assessment team.

  2. Myocardial Blush Grade 3

    Time frame: At the end of the index PCI procedure

    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.

  3. Complete ST-Segment Resolution

    Time frame: After PCI during the index hospitalization

    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.

  4. Any Stroke Through 30 Days

    Time frame: From randomization through 30 days

    The proportion of participants experiencing any adjudicated stroke.

  5. Major Adverse Cardiac or Cerebrovascular Events Through 6 Months

    Time frame: From randomization through 6 months

    Time to the first occurrence of all-cause death, recurrent myocardial infarction, stroke, rehospitalization for heart failure, or clinically indicated target-vessel revascularization.

  6. Major Adverse Cardiac or Cerebrovascular Events Through 12 Months

    Time frame: From randomization through 12 months

    Time to the first occurrence of all-cause death, recurrent myocardial infarction, stroke, rehospitalization for heart failure, or clinically indicated target-vessel revascularization.

  7. Cardiovascular Death

    Time frame: From randomization through 6 months and through 12 months

    Time to death adjudicated as cardiovascular in cause, reported at both 6 months and 12 months after randomization.

  8. All-Cause Death

    Time frame: From randomization through 6 months and through 12 months

    Time to death from any cause, reported at both 6 months and 12 months after randomization.

Other outcomes

  1. Additional Adjudicated Safety Events

    Time frame: From randomization through 12 months

    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.

  2. Procedural and Device-Related Complications

    Time frame: During the index PCI procedure and index hospitalization

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shenghua Zhou

CONTACT

[email protected]

073185292012

Sponsors and collaborators

Lead sponsor

Shenghua Zhou

Other

Collaborators

  • Capital Medical University
  • First Affiliated Hospital Xi'an Jiaotong University
  • Second Hospital of Jilin University
  • Second Xiangya Hospital of Central South University
  • The First Affiliated Hospital of Dalian Medical University
  • The General Hospital of Northern Theater Command

Registry information

Official study title

Percutaneous Coronary Intervention With or Without Manual Thrombus Aspiration in Patients With ST-Segment Elevation Myocardial Infarction and Angiographically Evident Thrombus

Acronym: TAPSET

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Oct 23, 2024
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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