Status:
COMPLETED
Closed Versus Open Cells Stent for Acute Myocardial Infarction
Lead Sponsor:
Alessandro Sciahbasi
Conditions:
Acute Myocardial Infarction
Primary Percutaneous Coronary Intervention
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of this study is to determine whether a closed cell stent design may reduce distal embolization and no reflow during primary percutaneous coronary intervention (PPCI) for acute ST-elevation ac...
Detailed Description
BACKGROUND Primary percutaneous coronary intervention (PPCI) represents the "gold standard" in the current management of patients with acute ST-elevation myocardial infarction (STEMI). Indeed, PPCI is...
Eligibility Criteria
Inclusion
- patients with an age \> 18 years with acute ST elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PPCI) within 12 hours from symptom onset and who agree and provide written informed consent. STEMI is defined as chest pain associated with ST-elevation of 1 mm or more in two or more contiguous leads or new left bundle-branch block within 12 hours after the onset of chest pain
Exclusion
- implanted stent with diameter \< 2.5 mm
- cardiogenic shock
- time from pain onset to PPCI \>12 hours
- previous thrombolytic therapy (rescue PPCI)
- inability to provide informed consent.
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
223 Patients enrolled
Trial Details
Trial ID
NCT01152138
Start Date
March 1 2010
End Date
December 1 2011
Last Update
May 17 2012
Active Locations (2)
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1
UOC Cardiologia - Policlinico Casilino - ASL RMB
Rome, Italy
2
UOC Cardiologia - Ospedale Belcolle
Viterbo, Italy