The Thrombus Aspiration During PCI After Thrombolysis in STEMI
NCT ID: NCT06654453
Last Updated: 2024-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
3500 participants
INTERVENTIONAL
2024-11-01
2028-11-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Thrombectomy + PCI Arm
This group will receive thrombectomy combined with percutaneous coronary intervention.
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.
PCI-only Arm
PCI is an established treatment for STEMI, and you are comparing it to the experimental group that receives an additional thrombectomy procedure.
Percutaneous Coronary Intervention
Percutaneous Coronary Intervention, involving balloon angioplasty and stent placement to open blocked coronary arteries in STEMI patients after thrombolysis.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Shenghua Zhou
OTHER
Responsible Party
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Shenghua Zhou
Director
Central Contacts
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Other Identifiers
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KYZ20240204
Identifier Type: -
Identifier Source: org_study_id
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