Coronary Aspiration Catheter Clinical Trial

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)

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

Study Overview

• Status: Recruiting
• Conditions: ST-segment Elevation Myocardial Infarction (STEMI)
• Intervention / Treatment: Device: Aspiration Catheter; Device: Export Advance Aspiration Catheter

• Study Type: Interventional
• Enrollment (Estimated): 144
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ge Junpo, Ph.D; Phone Number: 021-31587851; Email: ge.junbo@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Recruiting
      • Zhongshan Hospital, Fudan University
      • Contact: Ge Junbo, Ph.D; Phone Number: 021-31587871; Email: ge.junbo@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Group; Thrombus aspiration therapy using the test device	Device: Aspiration Catheter; Thrombus aspiration using Aspiration Catheter
Experimental: Control Group; Thrombus aspiration therapy using the control device	Device: Export Advance Aspiration Catheter; Thrombus aspiration using Export Advance Aspiration Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of TIMI flow grad 3 after PCI	Defined as the percentage of subjects with TIMI flow graded 3 after PCI.	Immediately after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TIMI flow after PCI	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	Immediately after procedure
MBG	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.	Immediately after procedure
TIMI Thrombus Grade	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.	Immediately after procedure
STR(ST-segment resolution) at 90 minutes	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.	Day 0
Thrombus aspiration time and number of aspirations	Record and compare the total thrombus aspiration time and number of aspirations in both groups.	Immediately after procedure
Device technical success rate	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.	Immediately after procedure
MACE	MACE includes cardiovascular death, recurrent myocardial infarction, all strokes, and target vessel revascularization (TVR)	30-day follow-up after procedure
AE and SAE	Incidence of all adverse events, serious adverse events in both groups	30-day follow-up after procedure

Collaborators and Investigators

• Sponsor: BrosMed Medical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2025
• Primary Completion (Estimated): February 20, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: April 23, 2025
• First Submitted That Met QC Criteria: April 23, 2025
• First Posted (Actual): April 30, 2025

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 23, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Necrosis; Myocardial Ischemia; Ischemia; ST Elevation Myocardial Infarction; Myocardial Infarction; Infarction
• Other Study ID Numbers: D23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No