Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00370578
Status:
UNKNOWN
Last Update Posted:
2007-08-28
First Post:
2006-08-09
Brief Title:
Aspiration Device in Myocardial Infarction Trial
Sponsor:
HaEmek Medical Center Israel
Organization:
HaEmek Medical Center Israel
Study Overview
Official Title:
Aspiration Device Myocardial Infarction Trial
Status:
UNKNOWN
Status Verified Date:
2006-08
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:
Early promising data are published focusing on the role of manual thrombus aspiration devices in patients with ST segment elevation STEMI
The aim of our single center randomized study is to evaluate the early and late effect of thrombus aspiration device AD after every stage during Primary PCI in the set-up of STEMI population
Our hypothysis is that preforming thrombus aspiration after every stage of primary PCI may give early and late advantages compared to the standard primary PCI technique
The aim of our single center randomized study is to evaluate the early and late effect of thrombus aspiration device AD after every stage during Primary PCI in the set-up of STEMI population
Our hypothysis is that preforming thrombus aspiration after every stage of primary PCI may give early and late advantages compared to the standard primary PCI technique
Detailed Description:
ADMIT-Randomized Single Center Study with two arms
Standard PCI versus Primary PCI using thrombus aspiration device after ever step of the procedure
Issues to be examined are
1 Immediate angiographic differences between the study arms By evaluation of TIMI FLOW GRADETIMI FRAME COUNTMYOCARDIAL BLUSH GRADE No reflow phenomenae
2 Infarc size evaluated by serum markers and non invasive parameters
3 In hospital major adverse cardiac events
4 Major adverse cardiac events during 30 180 days of follow up
Standard PCI versus Primary PCI using thrombus aspiration device after ever step of the procedure
Issues to be examined are
1 Immediate angiographic differences between the study arms By evaluation of TIMI FLOW GRADETIMI FRAME COUNTMYOCARDIAL BLUSH GRADE No reflow phenomenae
2 Infarc size evaluated by serum markers and non invasive parameters
3 In hospital major adverse cardiac events
4 Major adverse cardiac events during 30 180 days of follow up
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Yoav Turgeman MD | None | None | None |