Spectranetics announced that the EXCITE ISR trial achieved the statistical endpoints of the adjunct analysis. According to a company press release, the trial evaluates laser atherectomy plus percutaneous transluminal angioplasty compared with percutaneous transluminal angioplasty alone for the treatment of in-stent restenosis (ISR) in patients suffering from peripheral artery disease.
The EXCITE adjunct analysis, which was approved by the FDA in May 2013, allowed for multiple interim data analyses during the randomised trial. Statistical success was achieved based on enrolment of 250 patients at 35 sites across the US.
The press release reports that Spectranetics designed this treatment-to-control trial to show safety and effectiveness of treatment with laser atherectomy. Freedom from target lesion revascularisation at six months was hypothesised to be 70% in the laser atherectomy plus percutaneous transluminal angioplasty arm, and 53% for percutaneous transluminal angioplasty alone to prove statistical superiority. This benchmark was exceeded, which demonstrated early success.
According to Eric J Dippel, Genesis Medical Centre, Iowa, USA, and primary investigator, “EXCITE is a landmark randomised, controlled trial that represents a major step forward in treating patients with in-stent restenosis. This is a very large patient population that has suffered from insufficient, unproven treatment for too long.”
The trial’s largest enroller, Satyaprakash Makam, Cardiovascular Research of Northwest Indiana, states, “Many in-stent restenosis patients are in poor health. Stent replacement is not an option, and balloon angioplasty sometimes lasts just weeks. The data from this trial has the power to change clinical practice and improve patient care in this challenging disease state.”
The company anticipates submitting the 510(k) application to the US Food and Drug Administration (FDA) in the next 45 days. FDA review of a 510(k) application with clinical data takes an average of five months.