Using an aspiration catheter for treating heart attacks
Official title: A Prospective, Multicenter, Randomized Controlled, Noninferiority Clinical Trial Evaluating the Efficacy and Safety of an Aspiration Catheter in Patients Undergoing PCI for Acute ST-Segment Elevation Myocardial Infarction (STEMI)
Run by BrosMed Medical Co., Ltd · NCT06951724 · Data updated 2026-11-12
This study tests whether using a special catheter can help remove blood clots from the heart arteries during a heart attack to improve blood flow and patient recovery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 144 (estimated) |
| Sponsor | BrosMed Medical Co., Ltd Industry-sponsored |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | February 20, 2025 |
| Main results expected | February 20, 2026 |
| Study ends | June 30, 2026 |
| Registry record updated | April 30, 2025 |
| Trial ID | NCT06951724 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-80 who have been diagnosed with acute STEMI within 24 hours of symptom onset.
✕Probably not a fit
Patients with previous interventions in the target vessel, severe renal failure, or serious coagulation abnormalities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the efficacy and safety of an aspiration catheter in patients undergoing percutaneous coronary intervention (PCI) for acute ST-segment elevation myocardial infarction (STEMI). The study aims to determine how well the catheter can remove thrombus from the coronary arteries to improve blood flow and patient outcomes. Participants will be monitored for both the effectiveness of the intervention and any potential safety concerns during the procedure.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery outcomes for patients experiencing STEMI.
How similar studies have gone: Other studies have shown promising results with similar aspiration catheter approaches in treating STEMI, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:
\- General inclusion criteria
1. Age 18-80 years old (inclusive);
2. Clinical diagnosis of acute ST-segment elevation myocardial infarction (STEMI) within 24 hours of the onset of the disease (where ST-segment elevation is defined as ST-segment elevation of ≥1mm or 0.1mV in 2 or more consecutive leads of the 12-lead ECG);
3. Voluntary participation and signed written informed consent. Imaging Inclusion Criteria
4. DSA image showed that the target lesion was in situ coronary artery lesion;
5. Target vessel TIMI thrombus load classification ≥ grade 3 and TIMI flow classification ≤ grade 1;
Exclusion Criteria:
\- General exclusion criteria
1. previous PCI intervention or coronary artery bypass grafting (CABG) in the target vessel;
2. Comorbid cardiogenic shock;
3. severe renal failure or ongoing dialysis;
4. severe coagulation abnormalities (e.g., hypercoagulability due to blood disorders);
5. Failure of preoperative thrombolysis requiring remedial PCI;
6. Serious bleeding events requiring transfusion therapy within 30 days prior to surgery;
7. Ischemic stroke within 3 months prior to surgery;
8. Known allergy to anticoagulant and antiplatelet agents or contrast media;
9. female subjects who are known to be pregnant or lactating;
10. Participation or planned participation in other clinical studies of drugs or devices;
11. other conditions that the investigator evaluates to be unsuitable for participation in this trial.
Imaging exclusion criteria
12. Prognostic aspiration catheter needs to pass through the original stent mesh to reach the thrombus aspiration site;
13. severe calcification or tortuosity of the target vessel or extreme angulation that would interfere with the passage of the suction catheter;
14. the presence of an unprotected left main lesion (more than 50% narrowing of the lumen diameter);
15. the presence of severe triple coronary artery lesions requiring revascularization.
Where it's running
-
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Ge Junpo, Ph.D
- Email: ge.junbo@zs-hospital.sh.cn
- Phone: 021-31587851
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Adenosine given before primary PCI to reduce no-reflow in STEMI patients.
See if giving intracoronary adenosine before primary PCI lowers the chance of slow flow/no-reflow in adults with STEMI.
-
Using cardiac MRI and AI to predict outcomes after STEMI
This project will try to use routine cardiac MRI scans plus AI to see if imaging features can predict long-term outcomes in people who had a STEMI treated with primary PCI.
-
Using beta-blockers for heart attack patients in intensive care
This study is testing if the heart medication metoprolol can help heart attack patients in intensive care feel better and avoid worsening their condition.
-
Using machine learning to improve early diagnosis of acute cardiovascular conditions
This study is testing a new tool that uses advanced computer technology to help doctors quickly and accurately diagnose serious heart problems in patients who come to the emergency room with chest pain or trouble breathing.
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Administering adrenaline in STEMI patients during PCI to prevent no reflow
This study tests if giving adrenaline during heart procedures can help STEMI patients avoid complications with blood flow without causing heart rhythm problems.
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Comparing two treatments for heart attack patients with high thrombus burden
This study is testing if a new treatment for heart attack patients with a lot of blood clots works as well as an existing treatment and whether it causes more bleeding.
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.