Using an aspiration catheter for treating heart attacks
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)
NA · BrosMed Medical Co., Ltd · NCT06951724
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | BrosMed Medical Co., Ltd (industry) |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06951724 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 who have been diagnosed with acute STEMI within 24 hours of symptom onset.
Not a fit: Patients with previous interventions in the target vessel, severe renal failure, or serious coagulation abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery outcomes for patients experiencing STEMI.
How similar studies have performed: Other studies have shown promising results with similar aspiration catheter approaches in treating STEMI, indicating potential for success.
Eligibility criteria
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 this trial is running
Shanghai, Shanghai Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: ST-segment Elevation Myocardial Infarction