The first US patient has been enrolled in the Stellarex ILLUMENATE below-the-knee (BTK) investigational device exemption (IDE) study, led by principal investigators Bill Gray and Mahmood K Razavi. This global, prospective, randomised, multicentre trial is designed to assess safety and effectiveness of the Stellarex 0.014 drug-coated balloon (DCB) versus percutaneous transluminal angioplasty (PTA) in patients with critical limb ischaemia (CLI).
The trial will enrol 354 patients at 45 sites in USA, Europe and Australia in the next 12–18 months. The first patient in the USA was enrolled by Craig Walker at the Cardiovascular Institute of the South in Houma, Louisiana, USA.
“Several studies have shown the safety and durability benefits of the Stellarex balloon,” says Mahmood K Razavi, St Joseph’s Hospital in Orange, USA and principal investigator of the ILLUMENATE BTK study. “This study will look at findings that continue to demonstrate the benefits of the Stellarex 0.014 DCB for BTK peripheral arterial disease (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 revascularisation and major amputation.”
The Stellarex 0.014” OTW drug-coated balloon is designed to restore and maintain blood flow to arteries in patients with peripheral arterial disease. The Stellarex 0.014 drug-coated balloon is CE marked and available in Europe.