The Thrombus Aspiration During PCI After Thrombolysis in STEMI

Last updated: February 25, 2026
Sponsor: Shenghua Zhou
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Defect

Blood Clots

Circulation Disorders

Treatment

Thrombectomy

Percutaneous Coronary Intervention

Clinical Study ID

NCT06654453
KYZ20240204
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosed with STEMI.

  2. No contraindications for thrombolysis and has received thrombolytic treatment.

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

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

Exclusion

Exclusion Criteria:

  1. Contraindications for thrombolysis.

  2. Cardiogenic shock.

  3. Need for coronary artery bypass grafting.

  4. Age less than 18 years.

  5. Life expectancy of less than 6 months.

  6. Unable to provide informed consent.

Study Design

Total Participants: 3500
Treatment Group(s): 2
Primary Treatment: Thrombectomy
Phase:
Study Start date:
November 01, 2024
Estimated Completion Date:
November 01, 2028

Connect with a study center

  • Department of General Surgery, The Second Xiangya Hospital of Central South University, No. 139, Middle Renmin Road, Changsha, 410011 Hunan, PR China

    Changsha 1815577, Hunan 1806691
    China

    Active - Recruiting

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