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The Thrombus Aspiration During PCI After Thrombolysis in STEMI

NCT06654453 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3500

Last updated 2026-02-27

No results posted yet for this study

Summary

The goal of this clinical trial is to determine whether thrombus aspiration combined with percutaneous coronary intervention (PCI) improves clinical outcomes in ST-segment elevation myocardial infarction (STEMI) patients with high thrombus burden post-thrombolysis, compared to PCI alone. The study population includes 3500 STEMI patients, confirmed by diagnosis, who are transferred to PCI centers after receiving thrombolysis and have no contraindications to thrombolysis.The main questions it aims to answer are:

1. Does thrombus aspiration reduce 30-day major adverse cardiovascular events (MACE), including cardiovascular death, recurrent myocardial infarction, stroke, or heart failure rehospitalization?
2. Can thrombus aspiration improve microcirculation and clinical outcomes for high thrombus burden patients after thrombolysis? Researchers will compare patients randomly assigned to receive thrombus aspiration combined with PCI versus those who receive PCI alone to evaluate the effects on reducing MACE and improving clinical recovery.

Participants will:

Undergo initial thrombolysis followed by transfer to PCI centers. Be randomly assigned in a 1:1 ratio to receive either thrombus aspiration combined with PCI or PCI alone.

Be followed for 30 days post-treatment to assess MACE and other clinical outcomes.

Conditions

  • ST-segment Elevation Myocardial Infarction

Interventions

PROCEDURE

Thrombectomy

Manual thrombectomy followed by Percutaneous Coronary Intervention (PCI), a procedure involving mechanical removal of thrombus before stent placement in coronary arteries to restore blood flow in STEM

PROCEDURE

Percutaneous Coronary Intervention

Percutaneous Coronary Intervention, involving balloon angioplasty and stent placement to open blocked coronary arteries in STEMI patients after thrombolysis.

Sponsors & Collaborators

  • Shenghua Zhou

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2028-11-01
Completion
2028-11-01

Countries

  • China

Study Locations

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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 NCT06654453 on ClinicalTrials.gov