The Food and Drug Administration (FDA) has given Elixir Medical the go ahead to start patient enrolment for its investigational device exemption (IDE) EXCELLA III clinical trial, which will be used to support pre-market approval of the company’s Desyne Nx novolimus-eluting stent system.
The Desyne Nx stent elutes a low dose of Elixir’s proprietary drug novolimus, an active metabolite of sirolimus, via an ultrathin durable coating. The EXCELLA III clinical trial will be a prospective, controlled, multicentre, single-blind study comparing Desyne Nx with the Resolute zotarolimus-eluting stent sysem (Medtronic) as control in a 2:1 randomisation of 2,051 patients recruited from US and International centres. The principal investigator for the EXCELLA III study is Martin B Leon, New York Presbyterian Hospital/Columbia University Medical Center, New York, USA.
The primary endpoint of the EXCELLA III trial is target lesion failure, a composite measure of safety and effectiveness at 12 months defined as cardiac death, myocardial infarction related to the target vessel, and clinically-indicated target lesion revascularisation. In addition, a subset of patients will be evaluated for angiographic endpoints, and all patients will be followed for five years.
“EXCELLA III will be a promising trial building upon the excellent and sustained clinical outcomes of the EXCELLA II trial,” said Leon. “I am excited about Desyne Nx’s potential to validate the safety and long-term performance in this large clinical trial.”
According to a company press release, the IDE approval for the EXCELLA III trial in the US follows the successful international commercial launch of Desyne, which gained CE mark approval based on the results of the EXCELLA II trial. The EXCELLA II trial was a randomised controlled study that enrolled 210 patients at 22 clinical centres in Europe, Australia, New Zealand, and Brazil. The three-year follow-up results were presented last October at the Transcatheter Therapeutics (TCT) Conference in Washington, DC, USA. The Desyne stent demonstrated both non-inferiority and superiority to the Zotarolimus-Eluting control stent for the primary endpoint of in-stent late lumen loss and achieved low clinical event rate through three years. The data collected from the global use of Desyne will be used to supplement the future pre-market approval application in the US for the Desyne Nx novolimus stent system.