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CLINICAL TRIALS

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. None of the STENTYS patients had a malapposed stent at 3 days, compared with 28% of the balloon-expandable stent patients. Results were published in JACC Cardiovasc Interv. 2012 Dec;5(12):1209-19.

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. Results at 12 months presented at PCR 2013 by Prof. G. Montalescot showed MACE of 9.3% and cardiac death of 2% which was comparable or better than other AMI studies. Two year results were presented at TCT 2014 by Dr M. Grundeken showing MACE of 11.2% and cardiac death of 2.3%.

The APPOSITION IV trial compares the safety and effectiveness of the STENTYS Sirolimus stent with the RESOLUTE stent. Endpoints include stent apposition and coverage at 4 and 9 months measured through OCT. Results at four and nine months were presented at PCR 2014 by Dr R.J. van Geuns and showed significantly better apposition and stent coverage at four months for the STENTYS arm. Nine month results showed no difference in apposition, strut coverage or MACE, but a significantly greater mean lumen diameter for the STENTYS arm. Late loss was 0.04mm for the STENTYS stent and 0.17mm for the Resolute stent.

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® BMS in the treatment of de novo stenotic lesions in coronary arteries in 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. The STENTYS Self-Apposing BMS is currently not available for sale in the U.S., and is for investigational use only. The APPOSITION V trial enrollment was discontinued in July 2014 due to slow enrollment.

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 OPEN II study, a 200-patient observational study, evaluates the longer term clinical benefit of the STENTYS Stent in coronary bifurcation lesions in a daily clinical practice setting. The primary endpoint is the MACE rate at 6 months and was presented at TCT 2013. MACE was 10.1%, all death was 0.5%, and stent thrombosis was only 1.0%. Results at 12 months were presented by Dr C. Naber at PCR 2014. MACE was 13%, all death was 1.4% and stent thrombosis was 2.0%.

ADEPT Clinical Program

The “ADEPT” clinical trial program is designed to test the safety and performance of the STENTYS stents in coronary artery bypass grafts (CABG).

The “ADEPT” trial was a randomized trial (STENTYS BMS vs STENTYS DES(P)) in 57 patients with de novo stenosis in a coronary graft. The primary end point was late loss at 6 months. Results were presented at PCR 2014 showing a BMS late loss of 0.71mm and a DES late loss of 0.4mm. MACE was not different between the two arms – 11.1% for BMS and 10% for DES. All death was 3.7% for the BMS arm and 0% for the DES arm.

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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Updated 2017-04-03