Coronary Aspiration Catheter Clinical Trial

BrosMed Medical

Status: Enrolling

Conditions: ST-segment Elevation Myocardial Infarction (STEMI)

Treatments: Device: Export Advance Aspiration Catheter; Device: Aspiration Catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT06951724

D23

Details and patient eligibility

About

To evaluation of the efficacy and safety of an aspiration catheter in patients undergoing PCI for acute ST-segment elevation myocardial infarction (STEMI).

Enrollment: 144 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

144 participants in 2 patient groups

Test Group

Experimental group

Description:

Thrombus aspiration therapy using the test device

Treatment:

Device: Aspiration Catheter

Control Group

Experimental group

Description:

Thrombus aspiration therapy using the control device

Treatment:

Device: Export Advance Aspiration Catheter