ST-segment Elevation Myocardial InfarctionTAPSETNCT06654453
Manual Thrombus Aspiration During PCI in STEMI With Angiographically Evident Thrombus
A study testing Manual thrombus aspiration and Percutaneous Coronary Intervention in people with ST-segment Elevation Myocardial Infarction, run by Shenghua Zhou at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ST-segment Elevation Myocardial Infarction
- What is being tested?
- Manual thrombus aspiration and Percutaneous Coronary Intervention
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,500 participants
- Where
- 1 siteChina
- Study dates
- 9 Jul 2025to 30 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Cardiology, The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Shenghua Zhou, MD, +86-731-85292012, zhoushenghua@csu.edu.cn
About this study
Official title: 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.
Read the 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.
- Being tested
- Manual thrombus aspiration, Percutaneous Coronary Intervention
- Keywords
- ST-segment elevation myocardial infarction, Thrombus aspiration, Percutaneous coronary intervention, Randomized controlled trial, Angiographically evident thrombus, Coronary thrombus, Myocardial reperfusion, TAPSET
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual thrombus aspirationProcedure or surgery
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 InterventionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Manual Thrombus Aspiration + PCI | Experimental | Participants undergo manual aspiration of angiographically evident thrombus in the culprit coronary artery using the Sniffer II thrombus aspiration catheter, followed by PCI. Receives: Procedure: Manual thrombus aspiration; Procedure: Percutaneous Coronary Intervention |
| PCI Alone | Active comparator | Participants undergo PCI without planned thrombus aspiration. Receives: Procedure: Percutaneous Coronary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From randomization through 30 days
Secondary outcomes (8)
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.
Measured: At the end of the index PCI procedure
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.
Measured: At the end of the index PCI procedure
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.
Measured: After PCI during the index hospitalization
Any Stroke Through 30 Days
The proportion of participants experiencing any adjudicated stroke.
Measured: From randomization through 30 days
Major Adverse Cardiac or Cerebrovascular Events 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.
Measured: From randomization through 6 months
Major Adverse Cardiac or Cerebrovascular Events 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.
Measured: From randomization through 12 months
Cardiovascular Death
Time to death adjudicated as cardiovascular in cause, reported at both 6 months and 12 months after randomization.
Measured: From randomization through 6 months and through 12 months
All-Cause Death
Time to death from any cause, reported at both 6 months and 12 months after randomization.
Measured: From randomization through 6 months and through 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start9 Jul 2025
- Primary completion30 Jul 2028 (estimated)
- Study completion30 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST-segment Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Investigator-initiated, multicenter, randomized, open-label, two-group parallel superiority trial with blinded endpoint assessment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenghua Zhou
- Sponsor type
- University, hospital or other
- Collaborators
- Second Xiangya Hospital of Central South University, The General Hospital of Northern Theater Command, Second Hospital of Jilin University, First Affiliated Hospital Xi'an Jiaotong University, The First Affiliated Hospital of Dalian Medical University, Capital Medical University
- Responsible party
- Sponsor-investigator, Shenghua Zhou, Second Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654453
- Sponsor's protocol ID
- KYZ20240204
- Other IDs
- 2023ZD0503705
- Acronym
- TAPSET
- Status last verified
- Sep 2026
- First submitted
- 20 Oct 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to participant privacy considerations and restrictions related to informed consent and institutional data-governance requirements.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Coronary Intervention With or Without Manual Thrombus Aspiration in Patients With ST-Segment Elevation Myocardial Infarction and Angiographically Evident Thrombus
- ClinicalTrials.gov ID
- NCT06654453
- Acronym / sponsor ID
- TAPSET / KYZ20240204
- Keywords
- ST-segment elevation myocardial infarction, Thrombus aspiration, Percutaneous coronary intervention, Randomized controlled trial, Angiographically evident thrombus, Coronary thrombus, Myocardial reperfusion, TAPSET
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- Shenghua ZhouUniversity, hospital or other
- Collaborators
- Second Xiangya Hospital of Central South University, The General Hospital of Northern Theater Command, Second Hospital of Jilin University, First Affiliated Hospital Xi'an Jiaotong University, The First Affiliated Hospital of Dalian Medical University, Capital Medical University
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 30 Jul 2029 (estimated)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Investigator-initiated, multicenter, randomized, open-label, two-group parallel superiority trial with blinded endpoint assessment.
| Arm | Type | Receives |
|---|---|---|
| Manual Thrombus Aspiration + PCI | Experimental | Procedure: Manual thrombus aspiration, Procedure: Percutaneous Coronary InterventionParticipants undergo manual aspiration of angiographically evident thrombus in the culprit coronary artery using the Sniffer II thrombus aspiration catheter, followed by PCI. |
| PCI Alone | Active comparator | Procedure: Percutaneous Coronary InterventionParticipants undergo PCI without planned thrombus aspiration. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual thrombus aspirationManual 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 or surgery | Manual Thrombus Aspiration + PCI |
| Percutaneous Coronary InterventionPCI 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. | Procedure or surgery | Manual Thrombus Aspiration + PCI, PCI Alone |
Primary outcome
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.
8 secondary outcomes
Final TIMI Flow Grade 3
Time frame: At the end of the index PCI procedure
Myocardial Blush Grade 3
Time frame: At the end of the index PCI procedure
Complete ST-Segment Resolution
Time frame: After PCI during the index hospitalization
Any Stroke Through 30 Days
Time frame: From randomization through 30 days
Major Adverse Cardiac or Cerebrovascular Events Through 6 Months
Time frame: From randomization through 6 months
Major Adverse Cardiac or Cerebrovascular Events Through 12 Months
Time frame: From randomization through 12 months
Cardiovascular Death
Time frame: From randomization through 6 months and through 12 months
All-Cause Death
Time frame: From randomization through 6 months and through 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No. IPD will not be shared due to participant privacy considerations and restrictions related to informed consent and institutional data-governance requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual thrombus aspiration and Percutaneous Coronary Intervention in people with ST-segment Elevation Myocardial Infarction, run by Shenghua Zhou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shenghua Zhou (073185292012, zhoushenghua@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiac or Cerebrovascular Events (MACCE) Within 30 Days (time frame: From randomization through 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.