Spectranetics announced on 6 May 2013 FDA approval of its adjunct analysis plan associated with the EXCITE ISR clinical trial, studying the treatment of in-stent restenosis (ISR) in the legs. The goal of the adjunct analysis plan is to demonstrate statistically significant clinical superiority of laser atherectomy plus balloon angioplasty compared with angioplasty alone, prior to full enrolment of the EXCITE ISR study.
Spectranetics’ 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 six-month follow-up to be completed in a subset of patients.
The primary endpoints of the EXCITE ISR trial, freedom from target lesion revascularisation through six months and freedom from major adverse events at 30 days, remain unchanged. Major adverse events include all-cause mortality, major amputation in the target limb, or target lesion revascularisation.
“We are pleased to have achieved this meaningful step toward FDA approval of our therapy to treat in-stent restenosis,” said Scott Drake, president and chief executive officer. “The adjunct analysis provides a potentially streamlined path for improving patients’ lives and capitalising on this transformative global market opportunity, which we estimate at 250,000 procedures annually. We continue to target mid-2014 for commercialisation of the in-stent restenosis indication. Our commitment to prove clinical superiority over angioplasty treatment alone in in-stent restenosis patients is steadfast. Today, we are focused on completion of the EXCITE ISR trial and, in the future, we believe our ongoing PHOTOPAC study will show that laser atherectomy combined with drug-coated balloons is a next generation ISR treatment.”
“The approval of the adjunct analysis underscores the need for proven technologies to treat patients with in-stent restenosis. Today, these patients are largely treated using angioplasty alone with suboptimal clinical outcomes. No device on the market has the in-stent restenosis 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,” stated Eric Dippel, lead physician investigator for EXCITE ISR.
The EXCITE ISR trial will enrol a maximum of 318 patients at up to 35 sites. The PHOTOPAC study is a physician-sponsored, randomised, multicentre study conducted in Germany, comparing laser atherectomy plus drug-coated balloon to drug-coated balloon alone in patients with complex in-stent restenosis. The PHOTOPAC study was recently expanded from 50 patients to 125 patients. Spectranetics supports the study in the form of an unrestricted research grant.