Clinical trial NCT06951724: Coronary Aspiration Catheter Clinical Trial
Official title: A Prospective, Multicenter, Randomized Controlled, Noninferiority Clinical Trial Evaluating the Efficacy and Safety of an Aspiration Catheter in Patients Undergoing PCI for Acute ST-Segment Elevation Myocardial Infarction (STEMI)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ST-segment Elevation Myocardial Infarction (STEMI)
Lead sponsor: BrosMed Medical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2025-04-30
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: The rate of TIMI flow grad 3 after PCI
timeFrame: Immediately after procedure
Secondary outcomes:
measure: TIMI flow after PCI
timeFrame: Immediately after procedure
measure: MBG
timeFrame: Immediately after procedure
measure: TIMI Thrombus Grade
timeFrame: Immediately after procedure
measure: STR(ST-segment resolution) at 90 minutes
timeFrame: Day 0
measure: Thrombus aspiration time and number of aspirations
timeFrame: Immediately after procedure
measure: Device technical success rate
timeFrame: Immediately after procedure
measure: MACE
timeFrame: 30-day follow-up after procedure
measure: AE and SAE
timeFrame: 30-day follow-up after procedure
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
References: