STENTYS has launched an ambitious clinical program to demonstrate the safety and efficacy of its technology.
APPOSITION Clinical Program
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. Results were published in EuroIntervention 2011:7:428-436.
The APPOSITION II trial was a prospective, randomized, multi-centric, international clinical trial comparing STENTYS unique self-apposing technology to existing balloon-expandable stents in AMI patients. The primary endpoint was stent strut apposition under OCT at 3 days. Results showed that the STENTYS stent apposes perfectly to the vessel wall compared to a balloon-expandable stent.
The APPOSITION III study is a large, real-world, 1000-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. Excellent 30 day data were already presented at PCR 2012. Interim results on 600 patients with one year follow-up were presented at TCT 2012. Final one-year data will be presented on March 9, 2013 during ACC.
The ongoing APPOSITION IV trial compares the safety and effectiveness of the STENTYS Sirolimus stent with the RESOLUTE stent. Endpoint is stent apposition at 9 months measured through OCT.
The APPOSITION V trial is a prospective, multi-center, randomized, two-arm clinical trial to evaluate the safety and effectiveness of the STENTYS Self-Apposing® Stent in the treatment of de novo stenotic lesions in coronary arteries in 880 patients undergoing primary revascularization due to ST-elevation myocardial infarction (STEMI) as compared to the Multi-Link Vision™ coronary system (Abbott Vascular, Inc.). The trial’s primary endpoint is target vessel failure (TVF) at 12 months post-procedure. Fifty sites are expected to participate worldwide. Enrollment is expected to begin during the first half of 2013.
OPEN Clinical Program
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 (60 patients) showed that the creation of an opening in the STENTYS stent followed by the placement of a stent in the side branch if needed, is feasible and safe. Results were published in Eurointervention 2011;7:580-587. They showed excellent procedural success and a relatively low MACE (3.7%) at six months for the DES version. The disconnectable struts offered excellent ‘cross over’ to T-stenting when necessary.
The ongoing OPEN II study, a 200-patients observational study, evaluates the longer term clinical benefit of STENTYS Stent in coronary bifurcation lesions in a daily clinical practice setting. The primary endpoint is MACE rate at 6 months. A subgroup of 50 patients will also be assessed in terms of apposition at index procedure thanks to OCT imaging technology.
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.