Angioplasty Clinical Trial
Official title:
Aspiration Device Myocardial Infarction Trial
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.
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
GRADE,TIMI FRAME COUNT,MYOCARDIAL 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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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