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Efficacy of Thrombus Aspiration in Patients With Acute ST-Segment Elevation Myocardial Infarction: A Prospective, Multicenter, Randomized, Controlled, Single-Blind Clinical Trial

NCT07551700 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6760

Last updated 2026-04-27

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if adding standardized manual thrombus aspiration to primary percutaneous coronary intervention (PPCI) works better to improve heart health outcomes and protect long-term heart function in adults with acute ST-segment elevation myocardial infarction (STEMI) and a high blood clot burden in the heart's arteries. The main questions it aims to answer are:

* Does PPCI plus manual thrombus aspiration lower the risk of serious heart problems one year after treatment, compared to PPCI alone?
* Can manual thrombus aspiration better protect long-term heart function in people with a high blood clot burden? Researchers will compare two groups of participants-one group getting PPCI plus manual thrombus aspiration and one group getting only PPCI-to see if the aspiration treatment leads to fewer serious heart problems, better long-term heart function, and similar safety (including no higher risk of stroke).

Participants will:

* Have a heart artery scan (coronary angiography) to confirm a high blood clot burden
* Be randomly assigned to one of the two treatment groups for their PPCI procedure
* Complete follow-up checks at 30 days, 6 months, and 1 year after treatment, including heart function tests (like echocardiograms)
* Have heart magnetic resonance (CMR) scans if selected, to measure heart tissue damage and heart function
* Have their heart health status and any adverse events recorded throughout the study

Conditions

  • ST-segment Elevation Myocardial Infarction (STEMI)

Interventions

PROCEDURE

Manual Thrombus Aspiration

Manual thrombus aspiration is an adjunct to primary percutaneous coronary intervention (PPCI) for acute ST-segment elevation myocardial infarction (STEMI) patients with angiographically confirmed high thrombus burden (TIMI thrombus grade ≥3 or floating thrombus). Performed before stent implantation on the infarct-related vessel, the procedure uses a study-designated modern 6Fr-compatible manual aspiration catheter, with a 50ml large-volume locked syringe for stable negative pressure and heparinized normal saline for catheter flushing. Under fluoroscopy, the catheter is advanced 1-2cm distal to the thrombus, then retracted at a uniform speed of 1cm/sec with continuous negative pressure. Aspiration can be repeated up to 3 times if needed; successful aspiration is confirmed by visible thrombotic material and improved angiographic findings. No bailout aspiration is performed for failed cases, which proceed directly to routine balloon dilation and stent implantation.

PROCEDURE

Primary Percutaneous Coronary Intervention (PPCI)

Standard primary percutaneous coronary intervention with balloon dilation and stent implantation for STEMI

Sponsors & Collaborators

  • First Affiliated Hospital Xi'an Jiaotong University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2028-07-31
Completion
2028-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07551700 on ClinicalTrials.gov