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The Thrombus Aspiration During PCI After Thrombolysis in STEMI
Sponsor: Shenghua Zhou
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.
Official title: The Thrombus Aspiration During Percutaneous Coronary Intervention After Thrombolysis in ST-elevation Myocardial Infarction
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
3500
Start Date
2024-11-01
Completion Date
2028-11-01
Last Updated
2026-02-27
Healthy Volunteers
No
Interventions
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
Percutaneous Coronary Intervention
Percutaneous Coronary Intervention, involving balloon angioplasty and stent placement to open blocked coronary arteries in STEMI patients after thrombolysis.
Locations (1)
Department of General Surgery, The Second Xiangya Hospital of Central South University, No. 139, Middle Renmin Road, Changsha, 410011 Hunan, PR China
Changsha, Hunan, China