To better study the efficacy of the Combo Bio-engineered Sirolimus Eluting Stent (Combo Stent), OrbusNeich has announced that a clinical trial to evaluate the success of the Combo Stent is underway in patients with symptomatic, ischemic heart disease.
The study, REMEDEE ( Randomized Evaluation of an ablu Minal sirolimus coat ED bio- Engineered st Ent), will enroll 180 patients in 20 facilities throughout Asia, Australia, Europe and South America who have been diagnosed with heart disease as a result of a stenotic lesion located in a native coronary artery.
The trial will compare how the Combo Stent measures up to the Taxus Liberté Pacilitaxel-Eluting Stent (DES) when treating single coronary lesions ranging from 2.5 mm to 3.5 mm in diameter and up to 20 mm in length.
The study will measure how in-stent lumen loss in patients inserted with the the Combo stent compares to those inserted with the DES stent.
In addition, the trial will analyze how the stents balance when measuring rates of myocardial infarction, major adverse cardiac events (MACE) and stent thrombosis at 30-day, nine-month and five-year periods. Researchers also will analyze rates of target lesion revascularization (TLR), target vessel revascularization (TVR) and target lesion failure (TLF) at the same time frames.
According to OrbusNeich, the Combo stent integrates OrbusNeich’s Genous Bio-engineered R stent with Eden Prairie, Minn.-based SurModics’ SynBiosys biodegradable polymer matrixan (an abluminal sirolimus drug elution) to control neointimal proliferation.
The company reported that the first stent has been implanted into a cardiac patient at the John Hunter Hospital in Newcastle, Australia.
The projected end date of the study is scheduled for February 2015.