First Patient Enrolled in Bard's Lutonix In-Stent Restenosis Trial

March 18, 2014—Bard Peripheral Vascular (Tempe, AZ) announced the commencement of enrollment in the Lutonix In-Stent Restenosis (ISR) clinical trial conducted under an investigational device exemption (IDE). The trial is expected to enroll several hundred patients at 30 sites in the United States.

Lutonix ISR is a prospective, multicenter, single-blind, randomized controlled clinical trial that will compare the safety and efficacy of the Lutonix drug-coated balloon (DCB) to a standard angioplasty balloon for the treatment of femoropopliteal in-stent restenosis. Patients will be randomized 2:1 for treatment with a Lutonix DCB (study arm) or a standard noncoated angioplasty balloon (control arm).

The Lutonix DCB is designed to treat atherosclerotic lesions in the superficial femoral and popliteal arteries. The balloon is coated with a low dose of the antiproliferative paclitaxel drug with excipients sorbitol and polysorbate. The company describes the adhesion of the high-integrity coating as being intended to be durable enough to “stick” to the balloon during prep and transit while also allowing release of the drug to the target vessel during a 30-second balloon inflation. The coating is designed as an adjunct therapy to standard mechanical dilatation of the vessel to restore blood flow. 

Carlos Mena, MD, who is Medical Director of Vascular Medicine at Yale–New Haven Hospital, serves as Principal Investigator of the trial. “With today’s treatment limitations, ISR remains difficult to treat," Dr. Mena commented in the company’s press release. "I am excited to lead this groundbreaking study and for the potential to provide the medical community a new tool to treat patients with these complex challenges.”

Bard noted that the Lutonix ISR trial is one of several studies designed to produce long-term clinical evidence of the Lutonix DCB in order to expand treatment options for peripheral arterial disease. Results from the LEVANT 2 clinical trial have been submitted to the US Food and Drug Administration for approval of the Lutonix DCB in the United States.

The Lutonix DCB is not commercially available in the United States and is limited to investigational use under an FDA IDE. The Lutonix DCB is commercially available in Europe, advised the company.