First Patients Enrolled in Study of Self-Apposing Coronary Stent

May 2, 2011 – The mid-point for enrollment was reached in of the international APPOSITION III study of Stentys self-apposing coronary stent. About 250 patients are now enrolled out of a total of 500. The trial primary endpoint is major adverse cardiac events (MACE) at 12 months post-procedure.
 
“All cardiologists are extremely excited to be part of the APPOSITION III study and to routinely use the Stentys Self-Apposing Stent in treating AMI patients,” said study investigator Robert Jan van Geuns, M.D., Ph.D., Thorax Center at Erasmus Medical Center, Rotterdam, the Netherlands.
 
The stent is self-apposing to fit snugly into the contour of a blood vessel. Its shape and diameter adapt to the anatomic changes of the coronary arteries during the post-acute myocardial infarction (AMI) phase. The APPOSITION II randomized trial compared the Self-Apposing Stent with a conventional, market-leading stent in patients suffering a heart attack. It showed that, three days after an AMI, 28 percent of patients treated with conventional stents displayed significant malapposition, meaning that the stent was not completely in contact with the artery wall. Malapposition puts AMI patients at significant risk of potential fatal complications such as a blockage of the stent (in-stent thrombosis). In contrast, none of the patients treated with the Stentys stent had stent malapposition.
 
For more information: www.stentys.com