Thrombus removal during PCI after thrombolysis for STEMI
Official title: Percutaneous Coronary Intervention With or Without Manual Thrombus Aspiration in Patients With ST-Segment Elevation Myocardial Infarction and Angiographically Evident Thrombus
Run by Second Xiangya Hospital of Central South University · NCT06654453 · Data updated 2026-11-12
This trial will test whether removing clots during PCI improves outcomes for people with STEMI who received thrombolysis and have a high thrombus burden.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 3500 (estimated) |
| Sponsor | Second Xiangya Hospital of Central South University Academic / other |
| Locations | 1 site (Changsha, Hunan) |
| Status | Recruiting |
| Started | July 9, 2025 |
| Main results expected | July 30, 2028 |
| Study ends | July 30, 2029 |
| Registry record updated | September 9, 2026 |
| Trial ID | NCT06654453 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with STEMI who received thrombolysis, can have angiography within 2–24 hours, show TIMI thrombus grade ≥4 with >50% residual stenosis, have no contraindications to thrombolysis, and can give informed consent are ideal candidates.
✕Probably not a fit
Patients in cardiogenic shock, those needing urgent coronary bypass, those with contraindications to thrombolysis, with low thrombus burden, or who cannot meet the 2–24 hour angiography window are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized controlled trial will enroll about 3,500 patients with ST-segment elevation myocardial infarction who received thrombolytic therapy and were transferred for PCI. Eligible patients must undergo coronary angiography 2–24 hours after thrombolysis and have angiographic TIMI thrombus grade ≥4 with residual stenosis >50%. Participants are randomized to thrombus aspiration plus PCI or to PCI alone, with standard periprocedural care. The primary endpoint is 30-day major adverse cardiovascular events (cardiovascular death, recurrent MI, stroke, or heart failure rehospitalization) with secondary analyses including measures of microcirculation and other clinical outcomes.
Why it matters
Potential benefit: If successful, adding thrombus aspiration could lower 30-day major cardiac events and improve coronary microcirculation for high-thrombus STEMI patients after thrombolysis.
How similar studies have gone: Previous randomized trials of routine thrombus aspiration during primary PCI showed mixed or neutral results and some safety concerns like increased stroke risk, while targeted use after thrombolysis in high-thrombus patients is less well studied.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Department of Cardiology, The Second Xiangya Hospital of Central South University
Changsha, Hunan, China Recruiting
Study contacts
- Study coordinator: Shenghua Zhou
- Email: zhoushenghua@csu.edu.cn
- Phone: 073185292012
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.