Distal Protection Combined With PTCA in AMI Patients

Distal Protection Combined With PTCA in AMI Patients -- The DIPLOMAT Study.

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.

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 six-months post-procedure.

Inclusion Criteria:

• 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 Criteria:

• 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.