NCT06951724 Coronary Aspiration Catheter Clinical Trial
| NCT ID | NCT06951724 |
| Status | Recruiting |
| Phase | — |
| Sponsor | BrosMed Medical Co., Ltd |
| Condition | ST-segment Elevation Myocardial Infarction (STEMI) |
| Study Type | INTERVENTIONAL |
| Enrollment | 144 participants |
| Start Date | 2025-02-20 |
| Primary Completion | 2026-02-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 144 participants in total. It began in 2025-02-20 with a primary completion date of 2026-02-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To evaluation of the efficacy and safety of an aspiration catheter in patients undergoing PCI for acute ST-segment elevation myocardial infarction (STEMI).
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06951724 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying ST-segment Elevation Myocardial Infarction (STEMI). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06951724 currently recruiting?
Yes, NCT06951724 is actively recruiting participants. Contact the research team at ge.junbo@zs-hospital.sh.cn for enrollment information.
Where is the NCT06951724 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06951724 clinical trial?
NCT06951724 is sponsored by BrosMed Medical Co., Ltd. The trial plans to enroll 144 participants.