Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-28 @ 7:50 AM
Study NCT ID:
NCT02606435
Status:
UNKNOWN
Last Update Posted:
2015-11-17
First Post:
2015-11-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thrombus Aspiration in Patients With STEMI
Sponsor:
Xijing Hospital
Organization:
Study Overview
Official Title:
Safety and Efficacy of Thrombus Aspiration in Patients With ST-segment Elevation Myocardial Infarction (STEMI)
Status:
UNKNOWN
Status Verified Date:
2015-11
Last Known Status:
RECRUITING
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, randomized study with blinded outcome assessment, comparing routine manual thrombus aspiration with no aspiration in patients with acute ST-segment elevation myocardial infarction (STEMI) underwent percutaneous coronary intervention (PCI).
Detailed Description:
This is a prospective, randomized study with blinded outcome assessment, comparing routine manual thrombus aspiration with no aspiration in patients with acute ST-segment elevation myocardial infarction (STEMI) underwent percutaneous coronary intervention (PCI). Patients who are diagnosed as STEMI and referred for PCI will be enrolled. They will be randomized 1:1 to either manual thrombus aspiration with PCI group or PCI alone group.The primary outcome is the composite of cardiovascular death, recurrent myocardial infarction (MI), cardiogenic shock, stroke, new or worsening NYHA class IV heart failure during 1 year follow-up. The secondary efficacy outcome are stent thrombosis, target vessel revascularization, left ventricular function and quality of life during 1 year follow-up.
Study Oversight
Has Oversight DMC:
True
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?: