Bard has announced the enrolment of the first patient in the Lutonix below-the-knee clinical trial at The Cardiac and Vascular Institute in Gainesville, USA. The purpose of this global, multicentre randomised investigational device exemption (IDE) trial is to compare the safety and effectiveness of the Lutonix 014 drug-coated PTA dilatation catheter to a standard angioplasty balloon for the treatment of critical limb ischaemia, according to a press release.
The Lutonix below-the-knee clinical trial is expected to enrol several hundred patients at 55 sites worldwide. Patients will be randomised (2:1) for treatment with a Lutonix catheter (study arm), or a standard non-coated angioplasty balloon (control arm). The principal investigators of the Lutonix clinical trial are:
- Patrick Geraghty, associate professor of Surgery and Radiology at Washington University School of Medicine, Washington, USA
- Jihad Mustapha, director of Endovascular Interventions, Metro Heart and Vascular, Metro Health Hospital, Wyoming, and associate professor of Medicine, Michigan State University, USA
- Marianne Brodmann, associate professor and assistant medical director, Division of Angiology, Medical University Graz, Austria
Arthur Lee from The Cardiac and Vascular Institute stated: “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 critical limb ischaemia.”
According to the company, the Lutonix is similar to a standard angioplasty balloon, but is coated with an anti-proliferative drug (paclitaxel) designed to help keep arteries open and prevent restenosis. The Lutonix catheter is not commercially available in the USA and is limited to investigational use under an IDE. The Lutonix catheter is commercially available in Europe.
The Lutonix below-the-knee trial is one of several studies designed to produce long-term clinical evidence of the Lutonix drug-coated balloon in order to expand treatment options for peripheral arterial disease. Lutonix completed enrolment of 476 randomised patients last July for the Levant 2 IDE study for femoral-popliteal use and is actively recruiting patients for the Levant 2 continued access safety study.