ILLUMENATE European Trial Evaluates Philips Spectranetics' Stellarex DCB at 2 Years

September 14, 2017—Royal Philips announced the 2-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating the efficacy of Philips Spectranetics' Stellarex 0.035-inch drug-coated balloon (DCB) for the treatment of peripheral arterial disease (PAD) compared to uncoated balloon angioplasty. Marianne Brodmann, MD, presented the data as a late-breaking trial at the VIVA 17, Vascular Interventional Advances, conference held September 11–14 in Las Vegas, Nevada.

According to the company, the ILLUMENATE EU RCT is part of a series of five trials evaluating the safety and efficacy of Stellarex for the treatment of superficial femoral artery and popliteal disease. The ILLUMENATE EU RCT study has independent evaluation, which includes a clinical events committee, a data safety and monitoring board, and assessment by angiographic and duplex ultrasound core laboratories.

The European trial is composed of 328 patients with PAD from 18 centers in Germany and Austria.

The results show that at 24 months, 75.9% of patients treated with Stellarex maintained blood flow through the treated segment of the diseased artery, assessed through blinded core-lab adjudicated patency. By comparison, 61% of patients treated with an uncoated balloon maintained blood flow at 24 months. The data show that Stellarex demonstrates higher efficacy and patency results, and longer treatment durability compared to an uncoated balloon, which is the current standard of care in the United States, noted the company.

In Philips' press release, Dr. Brodmann commented, "The Stellarex DCB produced durable results in this rigorous trial, validating earlier findings among the ILLUMENATE trial series. These consistent, top-tier outcomes are achieved with a low-dose balloon." Dr. Brodmann added, "Stellarex is the first low-dose DCB to demonstrate a significant treatment effect at 2 years."

Spectranetics launched the Stellarex device in Europe in January 2015 and received US Food and Drug Administration approval in July 2017. In August, Philips acquired Spectranetics. In May, the 1-year results of the ILLUMENATE EU RCT were published by Henrik Schroeder, MD, et al online ahead of print in Circulation.