Final Data Presented From Spectranetics' ILLUMENATE European RCT

August 10, 2016—The Spectranetics Corporation announced that the final 12-month results of the Stellarex drug-coated balloon (DCB) ILLUMENATE European randomized clinical trial (EU RCT) were presented at the Amputation Prevention Symposium (AMP) in Chicago, Illinois. The Stellarex DCB is designed to restore and maintain blood flow to the superficial femoral and popliteal arteries in patients with peripheral arterial disease. 

According to the company, the EU RCT trial enrolled 328 patients and randomized 295 patients to treatment with the Stellarex DCB or a percutaneous transluminal angioplasty (PTA).

At day 365, primary patency, per Kaplan-Meier survival estimates, was 89% for the DCB group and 65% for the PTA group. Freedom from clinically driven target lesion revascularization, per Kaplan-Meier survival estimates, was 94.8% for the DCB group and 85.3% for the PTA group. 

Prof. Marianne Brodmann, MD, who presented the data at AMP, commented in the Spectranetics press release, “While results clearly show a highly significant gain compared to PTA, they favorably match the highest rates of primary patency with a low drug dose.” Prof. Brodmann is with Medical University Graz, Austria.

Henrik Schöder, MD, who is with Jewish Hospital in Berlin, Germany, is the trial's National Principal Investigator. In the Spectranetics announcement, Dr. Schöder commented, “The Stellarex DCB produced outstanding results in this rigorous trial, validating its earlier first-in-human and interim ILLUMENATE Global studies. These consistent, high-quality outcomes are achieved with a low-dose drug balloon, making this device especially compelling. Physicians now have a powerful tool to prevent restenosis and improve their patients’ quality of life.”

In November 2015, Prakash Krishnan, MD, presented 2-year data from the ILLUMENATE first-in-human study at VIVA 15, the 13th annual Vascular InterVentional Advances meeting. 

In April 2016, Spectranetics announced that 12-month interim data from the ILLUMENATE Global study were presented by Global Principal Investigator Prof. Thomas Zeller, MD, at the Charing Cross Symposium in London, United Kingdom. On June 1, a more expansive 12-month interim analysis was presented by Prakash Krishnan, MD, at the New Cardiovascular Horizons annual conference held June 1–3 in New Orleans, Louisiana. 

Spectranetics launched the device in Europe in January 2015 after receiving CE Mark approval in December 2014. The Stellarex DCB is not for sale in the United States, where commercialization is anticipated in 2017.