Royal Philips has commenced patient enrolment for its Stellarex ILLUMENATE Below-the-Knee (BTK) Investigational Device Exemption (IDE) clinical trial in the US.
The global, prospective, randomised, multi-centre trial will compare the safety and effectiveness of the Philips’ Stellarex 0.014 drug-coated angioplasty balloon to percutaneous transluminal angioplasty (PTA) in critical limb ischemia (CLI) patients.
Around 354 subjects are set to be enrolled into the trial at 45 sites across the US, Europe and Australia over the next 12-18 months.
The primary objective of the study is to demonstrate the benefits, safety and durability of the drug-coated balloon in BTK peripheral artery disease (PAD).
ILLUMENATE BTK study principal investigator Mahmood Razavi said: “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 drug-coated balloon has been developed to restore and maintain blood flow to arteries in patients suffering from PAD.
It leverages EnduraCoat technology that helps reduce drug loss during transit and facilitates efficient drug delivery to the treatment site. The device has already secured the European CE-Mark.
Royal Philips Image Guided Therapy Devices business leader Christopher Barys said: “Peripheral artery disease below the knee is challenging and Philips is committed to providing proven clinical solutions that positively impact patient outcomes.
“With Stellarex BTK, we have the potential to improve patient outcomes and decrease re-admission costs for those suffering from this complex disease state, while providing clinicians with the necessary tools to confirm the right therapies for their patients.”
Covidien, a Medtronic company, divested the Stellarex drug-coated balloon to Spectranetics in November 2014. Philips later acquired Spectranetics last year for €1.9bn.