THE LASER-AMI STUDY - Excimer Laser Versus Manual Thrombus Aspiration in Acute Myocardial Infarction
NCT01826006 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 194
Last updated 2014-11-13
Summary
The occurrence of no-reflow phenomenon after recanalization of the infarct related artery in acute myocardial infarction is described in up to 40% of cases. This event is associated with a worse prognosis at follow up and an unfavourable left ventricular remodelling. Two main pathogenetic mechanisms cause no-reflow: distal embolization, ischemia-reperfusion injury and individual susceptibility. In such a context, Excimer Laser (EL) may play an important role in order to reduce the rate of microvascular obstruction.
Thus, in this randomized study we will assess the effect of EL versus Manual Thrombus Aspiration for ST elevation MI using ST segment resolution on standard 12 leads ECG as primary endpoint of myocardial reperfusion.
Conditions
Interventions
- DEVICE
-
Excimer laser
- DEVICE
-
Manual Thrombus Aspiration
Sponsors & Collaborators
-
Catholic University of the Sacred Heart
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-04-30
- Primary Completion
- 2015-04-30
Countries
- Italy
Study Locations
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