The Thrombus Aspiration During PCI After Thrombolysis in STEMI

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShenghua Zhou

About this trial

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.

Eligibility criteria

Qualifiers

Diagnosed with STEMI.

No contraindications for thrombolysis and has received thrombolytic treatment.

Undergoing coronary angiography within 2 to 24 hours post-thrombolysis.

Angiographic results confirm TIMI thrombus load ≥ 4 and residual stenosis > 50%.

Disqualifiers

Contraindications for thrombolysis.

Cardiogenic shock.

Need for coronary artery bypass grafting.

Age less than 18 years.

Trial design

Treatments tested in this trial

  • Thrombectomy
  • Percutaneous Coronary Intervention

Treatment groups

3,500 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Shenghua Zhou

Lead sponsor

Second Xiangya Hospital of Central South University

Sponsor institution