Enrollment Begins in ILLUMENATE BTK Study of Philips' Stellarex 0.014 DCB
November 12, 2018—Royal Philips announced enrollment of the first patient from the United States in the Stellarex ILLUMENATE below-the-knee (BTK) investigational device exemption study. The trial is led by Principal Investigators William A. Gray, MD, and Mahmood K. Razavi, MD.
According to the company, the Stellarex 0.014-inch over-the-wire drug-coated balloon (DCB) is designed to restore and maintain blood flow to arteries in patients with peripheral artery disease (PAD). The Stellarex 0.014 DCB received CE Mark approval and is available in Europe.
The global, prospective, randomized, multicenter ILLUMENATE BTK trial is designed to assess the safety and effectiveness of the Stellarex 0.014 DCB versus percutaneous transluminal angioplasty in patients with critical limb ischemia. The trial will enroll 354 patients at 45 sites in the United States, Europe, and Australia in the next 12 to 18 months. The first patient in the United States was enrolled by Craig Walker, MD, at the Cardiovascular Institute of the South in Houma, Louisiana.
In the company's announcement, Dr. Razavi commented, "Several studies have shown the safety and durability benefits of the Stellarex balloon. This study will look at findings that continue to demonstrate the benefits of the Stellarex 0.014 DCB for BTK PAD and its safety and durability for patients. Given the challenging chronic nature of BTK PAD, we are hoping to find that through sustained patency using Stellarex, we can improve healing and reduce target lesion revascularization and major amputation." Dr. Razavi is from St. Joseph's Hospital in Orange, California.