A pilot study of a novel paclitaxel-coated angioplasty catheter for lower extremity peripheral artery disease: a pilot study.

Aim: The aim of the study was to report our preliminary results and real-world experiences regarding the use of a novel paclitaxel-coated balloon catheter in a cohort of patients with lower extremity peripheral artery disease at different stages.

Material and methods: A prospective cohort pilot study was conducted and the study group was made up of a total of 20 patients with peripheral artery disease who underwent endovascular balloon angioplasty with BioPath 014 or 035, a novel paclitaxel-coated, shellac containing balloon catheter. Eleven patients had a total of 13 TASC II-A lesions, 6 patients had a total of 7 TASC II-B lesions, 2 patients had TASC II-C lesions, 2 patients had TASC II-D lesions.

Results: In 13 patients, a single attempt with a BioPath catheter was adequate to treat a total of 20 target lesions, whereas in 7 patients more than one attempt with a different sized BioPath catheter was necessary. In 5 patients, total or near-total occlusion in the target vessel was initially treated with an appropriate sized chronic total occlusion catheter. Thirteen (65%) patients had at least one categorical improvement in Fontaine classification and none had symptomatic worsening.

Conclusions: The BioPath paclitaxel-coated balloon catheter seems to offer a useful alternative to the similar devices for treatment of femoral-popliteal artery disease. These preliminary results warrant confirmation with further research to reveal the safety and efficacy of the device.