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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Thrombectomy
Procedure/SurgeryManual 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
Procedure/SurgeryPercutaneous Coronary Intervention, involving balloon angioplasty and stent placement to open blocked coronary arteries in STEMI patients after thrombolysis.
Treatment groups
3,500 Participants
are divided into 2 treatment groupsGroup A: Thrombectomy + PCI ArmExperimental treatment 2 interventions
Group B: PCI-only ArmActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
30-day Major Adverse Cardiovascular Events (MACE)
A composite of cardiovascular death, recurrent myocardial infarction, stroke, and rehospitalization for heart failure within 30 days post-intervention.
Time frame
From enrollment to the end of treatment at 4 weeksSecondary outcomes
1
Reperfusion Success
The percentage of patients achieving successful reperfusion as indicated by TIMI flow grade improvement (e.g., achieving TIMI 2 or 3 flow) after the intervention.
Time frame
Within 30 minutes post-PCI (Percutaneous Coronary Intervention)2
Follow-up MACE at 6 Months
The rate of major adverse cardiovascular events (including cardiovascular death, myocardial infarction, and stroke) occurring within 6 months post-intervention.
Time frame
From enrollment to the end of treatment at 6 months3
Follow-up all-cause mortality at 6 Months
The rate of all-cause mortality occurring within 6 months post-intervention.
Time frame
From enrollment to the end of treatment at 6 months4
Follow-up MACE at 12 Months
The rate of major adverse cardiovascular events (including cardiovascular death, myocardial infarction, and stroke) occurring within 12 months post-intervention.
Time frame
From enrollment to the end of treatment at 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Shenghua Zhou
Lead sponsor
Second Xiangya Hospital of Central South University
Sponsor institution
Source ClinicalTrials.gov