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Trial assessing drug-coated balloon for PAD underway
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The Spectranetics Corporation announced that enrollment is completed for the ILLUMNENATE Pivotal trial, which is evaluating the use of a drug-coated angioplasty balloon to treat patients with peripheral artery disease.
The Stellarex drug-coated balloon platform (Spectranetics) is intended to restore and maintain blood flow in leg arteries above the knee in this patient population, according to a company press release. The prospective, randomized ILLUMENATE Pivotal will include 300 patients with superficial femoral or popliteal artery lesions of 3 to 14 cm. Patients were enrolled at 42 U.S. sites.
The researchers will evaluate safety and efficacy at 12 months, along with 5 years of follow-up, according to the release.
ILLUMENATE Pivotal is one of five trials in the ILLUMENATE program, which includes a global registry of 371 nonrandomized patients, a European randomized trial, a pharmacokinetic study in 25 patients and a first-in-human study in 80 patients. In the first-in-human trial, researchers observed a primary patency rate of 89.5% at 12 months and of 80.3% at 24 months in patients who received the drug-coated balloon, and 85.8% were patients free from target lesion revascularization at 24 months, according to the release.
“As lesion complexity increases among patients being treated with minimally invasive techniques for PAD, I’m pleased to be part of this trial and the study of a new technology that will give physicians proven treatment outcomes and durable options for vascular care,” co-primary investigator Prakash Krishnan, MD, of Mount Sinai Medical Center, said in the release.
The Stellarex DCB platform received a CE mark in December 2014, but is not approved in the United States.
Disclosure: Krishnan reports consulting for Abbott Vascular and Covidien.