June 11, 2010 – A multicenter, randomized trial planned in the United States will compare laser ablation followed by adjunctive balloon angioplasty as compared to balloon angioplasty alone in treating to treat in-stent restenosis (ISR) in arteries above the knee. There is no device currently cleared or approved by the U.S. Food and Drug Administration (FDA) to treat ISR.
The planned trial will use the Spectranetics Corp. Turbo-Tandem and Turbo Elite laser ablation devices.
The company has an ongoing trial utilizing the Turbo Elite laser catheter. The PATENT trial is assessing patency as measured by duplex ultrasound at various intervals up to 12 months following the procedure. It will also assess safety as measured by adverse events up to 12 months following the procedure. A decision whether to continue enrollments in the PATENT clinical trial, which was originally designed as a feasibility trial, will be made once the FDA has completed its review of the company’s pre-investigational device exemption (IDE) submission for the randomized clinical. Until then, enrollments will continue in PATENT, which currently has 66 patients enrolled in five centers in Germany. The company intends to pursue publication of the data from the PATENT trial.
The company also plans to support a pilot study evaluating the use of laser ablation followed by a paclitaxel-coated angioplasty balloon (PTX PTA) compared with the use of PTX PTA alone in the treatment of in-stent lesions in above-the-knee arteries. The planned enrollment for the PHOTOPAC trial is 50 patients, which will be followed for up to one year following the procedure. Spectranetics’ support of the PHOTOPAC trial will be in the form of an unrestricted research grant.
For more information: www.spectranetics.com