CLINICAL TRIALS

STENTYS has launched an ambitious clinical program to demonstrate the safety and efficacy of its technology.

The “APPOSITION” clinical trial program is designed to show that the STENTYS unique, self-expanding technology can improve the treatment of acute myocardial infarction.

The APPOSITION I trial is a prospective, single-arm, multi-centric study to evaluate by IVUS and OCT the short and long-term effects of the implantation of a STENTYS stent after clot and spasm have been resolved. Interim results were presented in San Francisco at TCT 2009 and full 30 day results were presented in Rome at JIM 2010 by Prof. Christian Spaulding.

The APPOSITION II trial was the next important step in  our clinical program. APPOSITION II is a prospective, randomized, multi-centric, international clinical trial comparing STENTYS unique technology to existing balloon-expandable stents in AMI patients. The primary endpoint was stent strut apposition under OCT at 3 days  and results were presented at TCT 2010 by Dr Stefan Verheye, showing superiority for the STENTYS Stent.

The APPOSITION III study is a large, real-world, 500-patient registry designed to measure the long-term safety and performance of the STENTYS Stent. The primary endpoint is MACE at 12 months, with subsequent follow-up at two years. The 30-days results will be presented at TCT 2011.

The “OPEN” clinical trial program is designed to prove that the STENTYS unique platform can facilitate the treatment of coronary lesions that are in close proximity to a significant side branch.

The OPEN I Trial is a prospective, single-arm study to show that the creation of an opening in the stent, followed by the placement of a stent in the side branch if needed, is feasible and safe. Participants in this study are highly regarded interventional cardiologists from renowned clinics throughout Europe. The 30-day study results were presented by Dr. Stefan Verheye at TCT 2008, and published in the March 2009 issue of EuroIntervention. 6 month results of both the DES and BMS arms were presented at JIM 2010.

This study will be followed by randomized worldwide studies to compare the STENTYS stent with other devices and techniques.

FUTURE TRIALS

STENTYS will continue its endeavor to show, through scientific evidence, that its core technology brings significant benefits to clinicians and patients. If you are an experienced interventional cardiologist with a strong interest in clinical research, and would like to participate in the STENTYS clinical trial program, please contact us.

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