Spectranetics announced that it plans to initiate the EXCITE ISR (Excimer laser randomised 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 FDA.
The study will compare the safety and efficacy of excimer laser atherectomy utilising the Spectranetics’ Turbo-Tandem and Turbo Elite products in conjunction with balloon angioplasty, with that of balloon angioplasty alone in a 2:1 fashion on patients with femoropopliteal in-stent restenosis, a condition caused by the development of scar tissue within a previously implanted stent.
EXCITE ISR will enrol up to 353 patients at up to 30 sites in the USA, with first patient enrolment expected within 30 days. The primary safety endpoint will measure major adverse events defined as death, major target limb amputation and target lesion revascularisation through 30 days following the procedure. The trial’s primary efficacy endpoint is freedom from clinically-driven target lesion revascularisation, which will be evaluated at 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.
“We are very pleased to be able to start the EXCITE ISR trial and plan to enrol the first patient within the next 30 days,” stated Shar Matin, senior vice president of operations, Product Development and International. “There is currently no medical device cleared by the FDA to treat patients with in-stent restenosis. Spectranetics is proud to be on the leading edge of clinical research to evaluate laser atherectomy for the treatment of peripheral artery disease.”
Eric Dippel, national principal investigator for the EXCITE ISR trial and interventional cardiologist at Trinity Regional Health System in Bettendorf, Iowa, USA commented, “Effective treatment for in-stent restenosis in upper leg interventions has yet to be proven in a scientifically rigorous randomised trial. The intent of this trial is to provide evidence for laser atherectomy in this difficult patient population, and I am looking forward to initiating this landmark clinical trial.”