Acute Myocardial Infarction Clinical Trial
Official title:
APPOSITION V: Stentys Coronary Stent System Clinical Trial in Patients With Acute Myocardial Infarction
This study will test compare the Stentys Stent with the Multi-Link Vision™ stent system (Abbott Vascular Inc.)in patients with a heart attack. It is expected that the Stentys stent is not worse than the Vision stent.
Coronary artery disease continues to be the most common cause of morbidity and mortality in
the occidental world. Treatment of coronary atherosclerotic disease has been significantly
advanced by interventional cardiology, and in particular the advent of coronary arterial
stents. In comparison to angioplasty alone, stents have reduced the incidence of
angiographic as well as clinical restenosis, the recurrence of angina, the need for coronary
arterial bypass graft (CABG) surgery, the need for repeat revascularization and the
occurrence of major adverse cardiac events (MACE).However,problems remain due to failure to
achieve optimal stent apposition and normal myocardial reperfusion. Early stent
malapposition may be due to incomplete expansion or undersizing of balloon-expandable
stents. Several studies have emphasized the importance of early malapposition in the setting
of ST elevation MI, in which substantial thrombotic burden and the presence of diffuse
vasoconstriction may be contributory. The Stentys Coronary Stent System includes a
self-expanding bare metal (nitinol) stent on a rapid exchange (RX) delivery system. In view
of the theoretical implications of malapposition, the self-expanding property may offer a
potential benefit.
This study is designed to evaluate the safety and effectiveness of the Stentys Coronary
Stent System in the treatment of de novo stenotic lesions in coronary arteries in patients
undergoing primary revascularization due to AMI as compared to the Multi-Link Vision™
coronary stent system (Abbott Vascular Inc. The study is powered for non-inferiority of the
Stentys Coronary Stent System compared to the Vision Stent System.
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