Manual Thrombus Aspiration During PCI in STEMI With Angiographically Evident Thrombus (TAPSET)

September 3, 2026 updated by: Shenghua Zhou

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

3500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410011
        • Recruiting
        • Department of Cardiology, The Second Xiangya Hospital of Central South University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: Manual thrombus aspiration
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.
Procedure: Percutaneous Coronary Intervention
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.
Active Comparator: PCI Alone
Participants undergo PCI without planned thrombus aspiration.
Procedure: Percutaneous Coronary Intervention
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From randomization through 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the end of the index PCI procedure
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.
At the end of the index PCI procedure
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.
After PCI during the index hospitalization
Any Stroke Through 30 Days
Time Frame: From randomization through 30 days
The proportion of participants experiencing any adjudicated stroke.
From randomization through 30 days
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.
From randomization through 6 months
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.
From randomization through 12 months
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.
From randomization through 6 months and through 12 months
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.
From randomization through 6 months and through 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From randomization through 12 months
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.
During the index PCI procedure and index hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenghua Zhou

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2025

Primary Completion (Estimated)

July 30, 2028

Study Completion (Estimated)

July 30, 2029

Study Registration Dates

First Submitted

October 20, 2024

First Submitted That Met QC Criteria

October 21, 2024

First Posted (Actual)

October 23, 2024

Study Record Updates

Last Update Posted (Actual)

September 9, 2026

Last Update Submitted That Met QC Criteria

September 3, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KYZ20240204
  • 2023ZD0503705 (Other Grant/Funding Number: Development Center for Medical Science & Technology, National Health Commission of the People's Republic of China)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared due to participant privacy considerations and restrictions related to informed consent and institutional data-governance requirements.

IPD Sharing Time Frame

Beginning 3 months and ending 3 years after the publication of results

IPD Sharing Access Criteria

To access the IPD and supporting information, interested parties should contact the principal investigator or designated study coordinator.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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