Spectranetics has completed enrolment of 300 patients in the ILLUMENATE pivotal clinical study, a prospective, randomised controlled, multicentre study designed to assess the clinical performance of the Stellarex drug-coated angioplasty balloon used to restore and maintain blood flow to above-the-knee arteries of the leg in patients with peripheral arterial disease (PAD).
The ILLUMENATE pivotal study includes patients with superficial femoral or popliteal artery lesions, 3–14cm in length, and will assess the safety and efficacy of Stellarex at 12 months, with follow-up to five years. Enrolment is now complete for all five studies in the ILLUMENATE series of clinical studies.
“When it comes to patient care, physicians demand clinical results that demonstrate evidence-based outcomes,” stated Prakash Krishnan, Mount Sinai Medical Center, New York, USA, co-primary investigator and leading enrolment site. “As lesion complexity increases among patients being treated with minimally invasive techniques for peripheral arterial disease, I am 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.”
Completion of clinical study enrolment is a major step toward premarket approval with the US Food and Drug Administration (FDA), which will be filed after one-year follow-up visits with all patients are completed.
“Based on early clinical evidence from our first-in-human study demonstrating the favourable impact of Stellarex, we are pleased ILLUMENATE pivotal has achieved this critical milestone toward our FDA submission. Drug-coated balloons are a significant part of the vascular landscape and Krishnan and ILLUMENATE pivotal trial investigators are producing the clinical data that physicians require and patients deserve,” states Amanda Johnson, vice president, Regulatory and Medical Affairs, Spectranetics.