Enrollment Completed in ILLUMENATE Pivotal Study of Spectranetics' Stellarex DCB

July 29, 2015—Spectranetics Corporation announced that it has completed enrollment of 300 patients in the ILLUMENATE pivotal clinical study of the Stellarex drug-coated balloon (DCB) to treat peripheral artery disease. The study will be used to support the company’s premarket approval application with the US Food and Drug Administration, which will be filed after 1-year follow-up visits with all patients are completed. The Stellarex DCB platform received European CE Mark approval in December 2014 and was launched in Europe in January 2015.

According to Spectranetics, ILLUMENATE is prospective, randomized, controlled, multicenter study that is designed to assess the clinical performance of the Stellarex DCB to restore and maintain blood flow to above-the-knee arteries of the leg in 300 patients with peripheral artery disease at 42 sites in the United States and Austria. The ILLUMENATE pivotal study includes patients with superficial femoral or popliteal artery lesions that are 3 to 14 cm in length. It will assess the safety and efficacy of Stellarex at 12 months, with follow-up to 5 years.

The study’s Coprimary Investigator, Prakash Krishnan, MD, commented in the company’s press release, “When it comes to patient care, physicians demand clinical results that demonstrate evidence-based outcomes. As lesion complexity increases among patients being treated with minimally invasive techniques for peripheral arterial disease, I'm pleased to be part of this trial and the study of a new technology that will give physicians proven treatment outcomes and durable options for vascular care.” Dr. Krishnan is with Mount Sinai Medical Center in New York, New York, which is the study’s leading enrollment site.

The company advised that there are four ILLUMENATE clinical studies in addition to the ILLUMENATE pivotal trial. These five clinical studies are being used to evaluate the safety and efficacy of the Stellarex DCB platform to support United States and Canada regulatory filings.

The nonrandomized, multicenter ILLUMENATE first-in-human study evaluated 80 patients. Results included a primary patency rate of 89.5% at 12 months and 80.3% at 24 months. The rate of freedom from clinically driven target lesion revascularization was 90% at 12 months and 85.8% at 24 months.

The ILLUMENATE pharmacokinetic study is designed to evaluate drug levels in the blood in 25 patients enrolled at two sites. The ILLUMENATE European randomized trial, which is similar to the United States pivotal trial, enrolled 328 patients at 19 sites. The nonrandomized ILLUMENATE global registry enrolled 371 patients at 37 sites, reported Spectranetics.