Bard Begins Enrollment in Lutonix BTK Clinical Trial

June 4, 2013—Bard Peripheral Vascular (Tempe, AZ) announced commencement of enrollment in the Lutonix below-the-knee (BTK) clinical trial.

According to Bard, the purpose of this pivotal global, multicenter, randomized trial is to compare the safety and effectiveness of the Lutonix 014 drug-coated balloon (DCB) percutaneous transluminal angioplasty (PTA) dilatation catheter to a standard angioplasty balloon for the treatment of critical limb ischemia (CLI).

The Lutonix BTK clinical trial, which is being conducted under an investigational device exemption (IDE), is expected to enroll several hundred patients at 55 sites worldwide. Patients will be randomized (2:1) for treatment with a Lutonix 014 DCB catheter (study arm) or a standard noncoated angioplasty balloon (control arm).

The principal investigators of the Lutonix BTK clinical trial are Patrick Geraghty, MD, of Washington University Medical Center in St. Louis, Missouri; Jihad A. Mustapha, MD, of Metro Health Hospital and Michigan State University in Wyoming, Michigan; and Prof. Marianne Brodmann, MD, of Medical University Graz, Austria.

Arthur Lee, MD, from the Cardiac and Vascular Institute in Gainesville, Florida, where the trial's first patient was enrolled, stated in Bard's press release, “This patient population faces significant challenges and poor clinical outcomes. Drug-coated balloons potentially offer a new hope for more durable and long-term clinical outcomes for patients facing CLI.”

The company stated that the Lutonix 014 DCB catheter is coated with paclitaxel. The device is not commercially available in the United States and is limited to investigational use under an IDE. The Lutonix 014 DCB catheter is commercially available in Europe.

According to Bard, the Lutonix BTK 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. In July 2012, the company announced completion of enrollment of 476 randomized patients for the Levant 2 IDE study for femoral-popliteal use. Bard is actively recruiting patients for the Levant 2 Continued Access Safety Study. Bard acquired Lutonix, Inc. (Maple Grove, MN) in December 2011.