Abstract
A pilot study of a novel paclitaxel-coated angioplasty catheter for lower extremity peripheral artery disease: a pilot study
- Çanakkale Onsekiz Mart Medical School, University Hospital, Çanakkale, Turkey
- Department of Cardiovascular Surgery, Mersin City Hospital, Mersin, Turkey
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.
Keywords
peripheral artery disease, percutaneous transluminal angioplasty, drug-coated balloon, drug-eluting balloon, paclitaxel-coated balloon
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