The Spectranetics Corporation announced early success of the EXCITE ISR clinical trial, achieving highly significant statistical superiority in both safety and efficacy. Notably, this superior outcome was achieved without any borrowing from the PATENT registry. Based on this result, Spectranetics has concluded enrolment in the EXCITE ISR trial and will submit the 510(k) application to the Food and Drug Administration (FDA). FDA review of a 510(k) application with clinical data takes an average of five months.
According to Eric J Dippel, Genesis Medical Center, Davenport, 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. Showing a superior safety and efficacy result early and without borrowing from PATENT is compelling. This superior result was achieved in the most challenging lesion cohort relative to any IDE peripheral study previously conducted.”
In-stent restenosis occurs when a previously placed stent becomes occluded, or blocked, and is considered to be a challenging condition to treat. Spectranetics designed this treatment-to-control trial to show safety and efficacy of treatment with laser atherectomy in patients with in-stent restenosis. 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 following enrolment of 250 patients versus the 318 patients originally planned.