Ignite Creation Date:
2024-10-25 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06654453
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-20
Brief Title:
The Thrombus Aspiration During PCI After Thrombolysis in STEMI
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Thrombus Aspiration During Percutaneous Coronary Intervention After Thrombolysis in ST-elevation Myocardial Infarction
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Optimal
Brief 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 thrombolysisThe 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 11 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
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 11 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None