A Prospective, Multicenter, European Registry Investigating the Lutonix DCB Drug-Coated PTCA Catheter for the Treatment of In-Stent Restenosis within Bare-Metal Stents.
This ongoing two-year study enrolled 41 subjects between June and December of 2009 at clinical sites in Belgium, Germany and the Netherlands. The target population for this study was patients who presented with anginal symptoms due to a restenosis within a previously placed bare-metal stent in a coronary artery. Bare-metal in-stent restenosis has been a recognized problem in interventional cardiology for many years with current treatment options being limited or suboptimal. The Lutonix DCB balloon is being tested in this population as an alternative treatment for this condition. Six-month results for this clinical trial were released at the 2010 Transcatheter Therapeutics Conference in September in Washington D.C.
Click here to review the PERVIDEO study presentation from the 2010 TCT.
An Exploratory Study Investigating the Use of the Lutonix DCB Drug-Coated PTCA Catheter in Conjunction with Bare Metal Stenting in Patients with De Novo Coronary Lesions.
This ongoing two-year study enrolled 26 subjects between July and November of 2009 at 3 clinical sites in the Netherlands. The target population for this study was patients who presented with a symptomatic de novo coronary lesion. The objectives of this study were to utilize a highly specific imaging technology, optical coherence tomography (OCT), to measure the biological effect of the Lutonix DCB balloon, and to establish the safety of the Lutonix DCB balloon when used in conjunction with a bare metal stent. Six month results for this clinical trial are being released at the 2010 Transcatheter Therapeutics Conference in September in Washington D.C.
Click here to review the De Novo study presentation from the 2010 TCT.