Coronary Aspiration Catheter Clinical Trial

Launched by BROSMED MEDICAL CO., LTD · Apr 23, 2025

Keywords

ClinConnect Summary

The Coronary Aspiration Catheter Clinical Trial is studying a new device called an aspiration catheter to see how well it works and how safe it is for patients experiencing a serious heart condition known as ST-segment Elevation Myocardial Infarction (STEMI). This condition occurs when there is a blockage in the heart's arteries, and the trial aims to evaluate the effectiveness of this catheter during a procedure called PCI (Percutaneous Coronary Intervention). The trial is currently recruiting participants aged 18 to 80 who have been diagnosed with STEMI within the last 24 hours and meet certain health criteria.

If you or a family member are considering participation, you should know that eligible participants will be asked to sign a consent form and may undergo tests to ensure they meet the study guidelines. Those who have had previous heart surgeries, severe kidney issues, or certain blood disorders, among other exclusions, may not qualify. Participants will receive care as part of the study and will be monitored closely to understand the catheter's impact on their heart health. This trial represents an important step in finding better treatments for heart attacks, and your involvement could help advance medical knowledge in this area.

Gender

ALL

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.