The Thrombus Aspiration During PCI After Thrombolysis in STEMI (Optimal)

Shenghua Zhou

Status: Not yet enrolling

Conditions: ST-segment Elevation Myocardial Infarction

Treatments: Procedure: Thrombectomy; Procedure: Percutaneous Coronary Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06654453

KYZ20240204

Details and patient eligibility

About

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.

Enrollment: 3,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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3,500 participants in 2 patient groups

Thrombectomy + PCI Arm

Experimental group

Description:

This group will receive thrombectomy combined with percutaneous coronary intervention.

Treatment:

Procedure: Percutaneous Coronary Intervention

Procedure: Thrombectomy

PCI-only Arm

Active Comparator group

Description:

PCI is an established treatment for STEMI, and you are comparing it to the experimental group that receives an additional thrombectomy procedure.

Treatment:

Procedure: Percutaneous Coronary Intervention