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Recruiting Not applicable

Coronary Aspiration Catheter Clinical Trial

NCT06951724 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2025-02-20
Last updated
2025-04-30

Condition(s) studied

ST-segment Elevation Myocardial Infarction (STEMI)

Investigational drug(s) / intervention(s)

Aspiration CatheterExport Advance Aspiration Catheter

Aspiration Catheter: Thrombus aspiration using Aspiration Catheter

Export Advance Aspiration Catheter: Thrombus aspiration using Export Advance Aspiration Catheter

Study 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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • The rate of TIMI flow grad 3 after PCI — Immediately after procedure
    Defined as the percentage of subjects with TIMI flow graded 3 after PCI.

Trial sites (1)

FacilityCityRegionStatus
Zhongshan Hospital, Fudan University Shanghai Shanghai Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06951724 on ClinicalTrials.gov ↗ ← All trials in China