Status:
COMPLETED
Distal Protection Combined With PTCA in AMI Patients
Lead Sponsor:
Cordis US Corp.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary objective is to evaluate if use of the AngioGuard™ XP improves myocardial reperfusion after PTCA as assessed by ST segment resolution at the end of PTCA.
Detailed Description
This is a prospective, randomized, multicenter trial. Patients will be randomized either to be treated by PTCA only or in combination with the An-gioGuard™ XP device. The patients will be followed for...
Eligibility Criteria
Inclusion
- Acute myocardial infarction \< 12 hours with ST segment elevation \> 2 mm in at least 2 contiguous leads;
- Clinical indication of primary PTCA;
- De novo or restenotic lesions in native coronary vessel, single vessel treatment only;
- Target lesion stenosis is \> 80% (by visual estimation).
Exclusion
- Patient has unprotected left main coronary disease with \> 50% stenosis in case left coronary artery is treated;
- Patient has an ostial target lesion;
- Killip class \> 3.
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2004
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00264030
Start Date
March 1 2002
End Date
August 1 2004
Last Update
January 7 2008
Active Locations (1)
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1
Institut Cardiovasculaire Paris Sud
Massy, France, F - 91300