Expected to enroll 180 patients at 20 sites in Asia, Australia, Europe and South America
OrbusNeich has reported the initiation of patient enrollment in the randomised clinical trial of the combo bio-engineered Sirolimus Eluting Stent (Combo Stent).
Randomised evaluation of an abluminal sirolimus coated bio-Engineered stent (REMEDEE) is a prospective, randomised, multicenter study, which is expected to enroll 180 patients at 20 sites in Asia, Australia, Europe and South America.
The primary objective is to demonstrate the safety and effectiveness of the combo stent compared to the Taxus Liberte paclitaxel-eluting stent (DES) in the treatment of single de novo native coronary lesions.
The study population will consist of patients with symptomatic, ischemic heart disease due to a stenotic lesion located in a native coronary artery. The primary endpoint is in-stent late lumen loss of the combo stent compared to DES at nine months post-procedure.
Secondary endpoints include all-cause and cardiac mortality, myocardial infarction, major adverse cardiac event (MACE) and stent thrombosis rates at 30 days, nine months and one through five years, as well as clinically driven Target Lesion Revascularisation (TLR), Target Vessel Revascularisation (TVR) and Target Lesion Failure (TLF) rates at the same follow-up times.
The first patient enrolled in the remedee study is a 48 year old male with a lesion located in the proximal left anterior descending artery. The stent was successfully inserted at John Hunter Hospital in Newcastle, Australia, by Dr Greg Bellamy and Dr Sukumaran Thambar.
The combo stent is designed to combine the pro-healing technology used in OrbusNeich’s Genous bio-engineered R stent for endothelial coverage with an abluminal sirolimus drug elution for the control of neointimal proliferation. The low dose sirolimus elution is accomplished through the use of the SynBiosys biodegradable polymer matrix from SurModics.
Renu Virmani, president and medical director of CVPath Institute, said: “The combo stent has demonstrated significantly lower neointimal hyperplasia, improved endothelial coverage relative to commercially available drug-eluting stents and lower presence of inflammation and foreign body reaction in multiple pre-clinical studies.”
Al Novak, president and CEO of OrbusNeich, said: “We fully expect the Combo Stent to build on by expanding the potential applicability to those patients at highest risk of restenosis, without the longer term safety risks associated with today’s drug eluting stents.”