Status:
RECRUITING
Coronary Aspiration Catheter Clinical Trial
Lead Sponsor:
BrosMed Medical Co., Ltd
Conditions:
ST-segment Elevation Myocardial Infarction (STEMI)
Eligibility:
All Genders
18-80 years
Phase:
NA
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
- \- General inclusion criteria
- Age 18-80 years old (inclusive);
- 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);
- Voluntary participation and signed written informed consent. Imaging Inclusion Criteria
- DSA image showed that the target lesion was in situ coronary artery lesion;
- Target vessel TIMI thrombus load classification ≥ grade 3 and TIMI flow classification ≤ grade 1;
Exclusion
- \- General exclusion criteria
- previous PCI intervention or coronary artery bypass grafting (CABG) in the target vessel;
- Comorbid cardiogenic shock;
- severe renal failure or ongoing dialysis;
- severe coagulation abnormalities (e.g., hypercoagulability due to blood disorders);
- Failure of preoperative thrombolysis requiring remedial PCI;
- Serious bleeding events requiring transfusion therapy within 30 days prior to surgery;
- Ischemic stroke within 3 months prior to surgery;
- Known allergy to anticoagulant and antiplatelet agents or contrast media;
- female subjects who are known to be pregnant or lactating;
- Participation or planned participation in other clinical studies of drugs or devices;
- other conditions that the investigator evaluates to be unsuitable for participation in this trial.
- Imaging exclusion criteria
- Prognostic aspiration catheter needs to pass through the original stent mesh to reach the thrombus aspiration site;
- severe calcification or tortuosity of the target vessel or extreme angulation that would interfere with the passage of the suction catheter;
- the presence of an unprotected left main lesion (more than 50% narrowing of the lumen diameter);
- the presence of severe triple coronary artery lesions requiring revascularization.
Key Trial Info
Start Date :
February 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT06951724
Start Date
February 20 2025
End Date
June 30 2026
Last Update
April 30 2025
Active Locations (1)
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1
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200000