Coronary Aspiration Catheter Clinical Trial

Not Applicable

Recruiting

• Conditions: ST-segment Elevation Myocardial Infarction (STEMI)

• Registration Number: NCT06951724
• Lead Sponsor: BrosMed Medical Co., Ltd

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-20
• Status Verified: 2025-04
• Study First Submitted: 2025-04-23
• Study First Submitted QC: 2025-04-23
• Last Update Submitted: 2025-04-23
• Study First Posted: 2025-04-30
• Last Update Posted: 2025-04-30
• Primary Completion: 2026-02-20
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 144

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
AE and SAE	30-day follow-up after procedure	Incidence of all adverse events, serious adverse events in both groups
TIMI Thrombus Grade	Immediately after procedure	TIMI Thrombus Grade after coronary thrombus aspiration using either the test device or the control device. There are 6 levels of MBG. Grades range from 0 and up to 5, with higher grades being worse.
MACE	30-day follow-up after procedure	MACE includes cardiovascular death, recurrent myocardial infarction, all strokes, and target vessel revascularization (TVR)
Thrombus aspiration time and number of aspirations	Immediately after procedure	Record and compare the total thrombus aspiration time and number of aspirations in both groups.
Device technical success rate	Immediately after procedure	The test device or control device is able to successfully pass through all target lesions, complete thrombus aspiration, and successfully withdraw without complications relate to the procedure during thrombus aspiration, and TIMI flow grade 3 in the immediately after PCI.
STR(ST-segment resolution) at 90 minutes	Day 0	The index of change in the highest level of ST-segment elevation relative to the highest level of preoperative ST-segment elevation was assessed on the basis of electrocardiographic at 90 min ± 30 min after PCI.
TIMI flow after PCI	Immediately after procedure	Target vessel TIMI (Thrombolysis In Myocardial Infarction) flow grad after PCI, after completion of of coronary thrombus using the test device or control device to complete thrombus aspiration
MBG	Immediately after procedure	MBG (Myocardial Blush Grade) after coronary thrombus aspiration using either the test device or the control device. There are 4 levels of MBG. Grades range from 0 and up to 3, with higher grades being better.

Trial Locations

Locations (1)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China