Spectranetics to Initiate EXCITE ISR Clinical Trial

April 7, 2011—Spectranetics Corporation (Colorado Springs, CO) announced that it plans to initiate the EXCITE ISR (Excimer Laser Randomized Controlled Study for Treatment of Femoropopliteal In-Stent Restenosis) clinical trial following the recent conditional approval of the company's investigational device exemption application by the US Food and Drug Administration. Eric J. Dippel, MD, is the national principal investigator for the EXCITE ISR trial.

According to the company, the study will evaluate the safety and efficacy of excimer laser atherectomy using the Spectranetics Turbo-Tandem and Turbo Elite devices in conjunction with balloon angioplasty compared with balloon angioplasty alone in a 2:1 fashion in patients with femoropopliteal in-stent restenosis.

EXCITE ISR will enroll up to 353 patients at up to 30 sites in the United States. The company expects that the first patient will be enrolled within 30 days. The primary safety endpoint will measure major adverse events defined as death, major target limb amputation, and target lesion revascularization through 30 days postprocedure.

The trial's primary efficacy endpoint is freedom from clinically driven target lesion revascularization, which will be evaluated at 6 months postprocedure. These results will be included in a 510(k) filing with the US Food and Drug Administration. The study will employ three separate independent core laboratories and an independent data safety and monitoring board, noted the company.