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Coronary Aspiration Catheter Clinical Trial

NCT ID: NCT06951724

Last Updated: 2025-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-20

Study Completion Date

2026-06-30

Brief Summary

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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

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Conditions

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ST-segment Elevation Myocardial Infarction (STEMI)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Test Group

Thrombus aspiration therapy using the test device

Group Type EXPERIMENTAL

Aspiration Catheter

Intervention Type DEVICE

Thrombus aspiration using Aspiration Catheter

Control Group

Thrombus aspiration therapy using the control device

Group Type EXPERIMENTAL

Export Advance Aspiration Catheter

Intervention Type DEVICE

Thrombus aspiration using Export Advance Aspiration Catheter

Interventions

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Aspiration Catheter

Thrombus aspiration using Aspiration Catheter

Intervention Type DEVICE

Export Advance Aspiration Catheter

Thrombus aspiration using Export Advance Aspiration Catheter

Intervention Type DEVICE

Eligibility Criteria

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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);
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

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.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BrosMed Medical Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ge Junpo, Ph.D

Role: CONTACT

Phone: 021-31587851

Email: [email protected]

Facility Contacts

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Ge Junbo, Ph.D

Role: primary

Other Identifiers

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D23

Identifier Type: -

Identifier Source: org_study_id