Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-25 @ 11:44 PM
Study NCT ID:
NCT04212494
Status:
RECRUITING
Last Update Posted:
2024-11-18
First Post:
2019-12-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Thrombus Aspiration in STEMI Patients With High Thrombus Burden
Sponsor:
Guangdong Provincial People's Hospital
Organization:
Study Overview
Official Title:
Thrombus Aspiration in Primary Percutaneous Coronary Intervention for STEMI Patients With High Thrombus Burden
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective, multicenter, open-label, randomized, controlled, parallel group study, in which ST-segment Elevation Myocardial Infarction (STEMI) patients with high thrombus burden(TIMI thrombus grade ≥3) are included. Patients are randomized to be treated with or without manual thrombus aspiration(TA) during primary percutaneous coronary intervention(PPCI) by a ratio of 1:1.
Detailed Description:
This study is intended to explore the efficacy of thrombus aspiration (TA) in ST-Segment Elevation Myocardial Infarction (STEMI) patients with high thrombus burden who received primary PCI within 12 hours after the onset of symptoms, reducing the incidence of cardiovascular death, recurrent myocardial infarction, stent thrombosis, target vessel revascularization within 180 days or stroke in 30 days.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: