NCT06654453

The Thrombus Aspiration During PCI After Thrombolysis in STEMI

The Thrombus Aspiration During Percutaneous Coronary Intervention After Thrombolysis in ST-elevation Myocardial Infarction

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,500 (estimated)
• Sponsor: Shenghua Zhou · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-11-01
• Primary completion: 2028-11-01
• Completion: 2028-11-01
• First posted: 2024-10-23
• Last updated: 2026-02-27

Locations

1 site across 1 country: China