Spectranetics Finalizes EXCITE ISR Adjunct Analysis Plan

May 6, 2013—Spectranetics Corporation (Colorado Springs, CO) announced that the US Food and Drug Administration (FDA) has approved the company's adjunct analysis plan associated with the EXCITE ISR clinical trial, which is studying the treatment of in-stent restenosis (ISR) in the legs. The company stated that the goal of the adjunct analysis plan is to demonstrate statistically significant clinical superiority of laser atherectomy plus balloon percutaneous transluminal angioplasty (PTA) compared with PTA alone before full enrollment of the EXCITE ISR study.

According to the company, the adjunct analysis plan incorporates multiple interim data analyses of patients enrolled in the ongoing EXCITE ISR trial, with the potential to leverage data from the recently completed PATENT trial. The plan allows for 6-month follow-up to be completed in a subset of patients. The primary endpoints of the EXCITE ISR trial—freedom from target lesion revascularization (TLR) through 6 months and freedom from major adverse events (MAEs) at 30 days—remain unchanged. MAE includes all-cause mortality, major amputation in the target limb, or TLR.

“The approval of the adjunct analysis underscores the need for proven technologies to treat patients with in-stent restenosis,” commented EXCITE ISR Principal Investigator Eric Dippel, MD, in Spectranetics' announcement. “Today, these patients are largely treated using PTA alone with suboptimal clinical outcomes. No device on the market has the ISR indication, and successful completion of the EXCITE ISR trial will address a large, unmet clinical need for more durable outcomes in this difficult patient population."

Spectranetics advised that the EXCITE ISR trial will enroll a maximum of 318 subjects at up to 35 sites, randomized 2:1 to treatment or control. The treatment arm is laser atherectomy combined with PTA and the control arm is PTA alone. The primary efficacy endpoint is freedom from TLR through 6 months. The primary safety endpoint is freedom from MAE at 30 days. MAE includes all-cause mortality, major amputation in the target limb, or TLR.

PATENT is a prospective, single-arm registry and enrolled 90 patients at five sites in Germany. The patient population was similar to the EXCITE ISR study, and the patients were treated in a manner similar to EXCITE ISR's control arm. Results of the PATENT study were presented in January at LINC 2013: Leipzig Interventional Course in Leipzig, Germany. The results included 82% freedom from TLR at 6 months and a 2.2% MAE rate through 30 days postprocedure.