Covidien Initiates ILLUMENATE Trials for the Stellarex Peripheral Drug-Coated Balloon

July 15, 2013—Covidien (Mansfield, MA) has commenced enrollment in the ILLUMENATE Pivotal and ILLUMENATE PK (Pharmacokinetics) trials, which are components of the global ILLUMENATE clinical trial program. This program is a series of studies on the safety and effectiveness of Covidien's Stellarex drug-coated angioplasty balloon for the treatment of patients with peripheral arterial disease (PAD).

As summarized in the company's announcement, the ILLUMENATE Pivotal trial is a United States multicenter, prospective, randomized trial that is evaluating the safety and effectiveness of the Stellarex drug-coated angioplasty balloon versus an uncoated standard angioplasty balloon in the treatment of de novo blockages or reblockages of the superficial femoral or popliteal arteries. The trial is being conducted at up to 35 centers in the United States and will enroll up to 360 patients.

The National Principal Investigators for the ILLUMENATE Pivotal trial are Prakash Krishnan, MD, Director of Endovascular Services at the Cardiac Catheterization Lab at Mount Sinai Medical Center in New York, New York, and Sean Lyden, MD, Associate Professor at the Cleveland Clinic Lerner College of Medicine in Cleveland, Ohio.

In the company's press release, Dr. Krishnan commented, “PAD is a debilitating condition that presents significant treatment challenges for physicians. We continue to seek new, more effective treatment options, and I am confident that the results of the ILLUMENATE trials will support the use of a new device that will improve long-term durability of outcomes.”

The ILLUMENATE PK trial is a prospective, single-arm pharmacokinetics trial that will enroll up to 25 patients with de novo blockages or reblockages in the superficial femoral or popliteal arteries and will be treated with the Stellarex drug-coated peripheral angioplasty balloon. Andrew Holden, MD, enrolled the first patients in the ILLUMENATE PK trial on June 25, 2013, at The Auckland City Hospital, Grafton, in Auckland, New Zealand.

The European ILLUMENATE EU trial is a prospective, randomized trial comparing the safety and effectiveness of the Stellarex drug-coated balloon versus an uncoated standard angioplasty balloon. The trial is currently enrolling up to 360 patients at up to 30 European centers. Henrik Schroeder, MD, of the Center for Diagnostic Radiology and Minimally Invasive Therapy at The Jewish Hospital in Berlin, Germany, is the National Principal Investigator for this trial.

The prospective, single-arm ILLUMENATE Global trial will continue to evaluate the safety and effectiveness of the Stellarex drug-coated balloon in the treatment of de novo blockages and reblockages in the superficial femoral or popliteal arteries. The study will enroll up to 500 patients at up to 65 centers worldwide. Enrollment is anticipated to begin this summer.

Covidien announced in May that the 12-month results from the first study in the series—ILLUMENATE First-in-Human trial—were reported at the 2013 EuroPCR Scientific Congress; the Stellarex drug-coated angioplasty balloon demonstrated promising safety and effectiveness, with an 87% primary patency rate at 12 months.

The company notes that its Stellarex drug-coated angioplasty balloon is not commercially available and is limited to investigator use under an investigational device exemption in the United States and under applicable laws outside the United States.