COLORADO SPRINGS, Colo.--(BUSINESS WIRE)--Spectranetics Corporation (Nasdaq: SPNC) today announces the first patient enrollment in the EXCITE ISR (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis) clinical trial. The patient was treated by Dr. Prakash Makam at Community Hospital in Munster, Indiana. The EXCITE ISR clinical trial will enroll up to 353 patients at up to 30 sites in the U.S. The trial will study femoropopliteal in-stent restenosis (ISR), a condition caused by the development of neointimal hyperplasia within a previously implanted stent. The study will compare the safety and efficacy of excimer laser atherectomy utilizing the Spectranetics’ Turbo-Tandem and Turbo Elite products in conjunction with balloon angioplasty, compared with balloon angioplasty alone in a 2:1 randomized fashion. The primary safety endpoint of the trial will measure major adverse events defined as all-cause death, major target limb amputation or target lesion revascularization (TLR) through 30 days following the procedure. The primary efficacy endpoint of the trial is freedom from TLR (reintervention), which will be evaluated through six months following the procedure. These results will be included in a 510k filing with the FDA. The study will employ three separate independent core laboratories and an independent Data Safety and Monitoring Board in order to enhance the credibility and integrity of the study results.
