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Thrombus Aspiration in STEMI ...

Thrombus Aspiration in STEMI Patients With High Thrombus Burden

Last Updated: 2024-11-18

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

Total Enrollment

3838 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-30

Study Completion Date

2026-02-28

Brief Summary

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This is a prospective, multicenter, open-label, randomized, controlled, parallel group study, in which ST-segment Elevation Myocardial Infarction (STEMI) patients with high thrombus burden(TIMI thrombus grade ≥3) are included. Patients are randomized to be treated with or without manual thrombus aspiration(TA) during primary percutaneous coronary intervention(PPCI) by a ratio of 1:1.

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Detailed Description

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This study is intended to explore the efficacy of thrombus aspiration (TA) in ST-Segment Elevation Myocardial Infarction (STEMI) patients with high thrombus burden who received primary PCI within 12 hours after the onset of symptoms, reducing the incidence of cardiovascular death, recurrent myocardial infarction, stent thrombosis, target vessel revascularization within 180 days or stroke in 30 days.

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

NONE

Study Groups

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Thrombus aspiration

Upfront manual thrombus aspiration followed by PCI

Group Type EXPERIMENTAL

Thrombus aspiration

Intervention Type PROCEDURE

Percutaneous Coronary Intervention with manual aspiration thrombectomy

PCI Alone

PCI without upfront manual thrombus aspiration

Group Type ACTIVE_COMPARATOR

PCI Alone

Intervention Type PROCEDURE

Percutaneous Coronary Intervention without manual aspiration thrombectomy

Interventions

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Thrombus aspiration

Percutaneous Coronary Intervention with manual aspiration thrombectomy

Intervention Type PROCEDURE

PCI Alone

Percutaneous Coronary Intervention without manual aspiration thrombectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Age ≥ 18 years;
2. STEMI patients undergoing primary PCI within 12 hours after the onset of symptoms;
3. High thrombus burden after guidewire passes the lesion (TIMI thrombus grade ≥3);
4. Informed consent must be voluntary;

Exclusion Criteria

1. Haemodynamic instability or cardiogenic shock;
2. After thrombolytic therapy;
3. The predicted survival time is less than 6 months due to non-cardiac disease;
4. History of coronary artery bypass grafting;
5. Participate in other researches within 30 days;
6. Preoperative gastrointestinal bleeding or contraindications to dual antiplatelet therapy;
7. Patients were considered unsuitable by other researchers.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Locations

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