A Multicenter Randomized Trial Assessing ZENFlow Carrier-Free Drug-Coated Balloon for the Treatment of Femoropopliteal Artery Lesions.

ABSTRACT:

Backgrounds and objectives

Drug-coated balloons (DCBs) have shown promising benefits in improving the outcomes for patients with peripheral artery disease. Several randomized clinical trials have reported that paclitaxel-coated balloon significantly reduce the rates of restenosis and the need for reintervention in comparison with regular balloon angioplasty. Due to the differences in excipients, paclitaxel dose, and coating techniques, variable clinical outcomes have been observed with different DCBs. In this study, we aimed to evaluate the safety and efficacy of a novel ZENFlow carrier-free DCB in the treatment of femoropopliteal artery occlusive disease.

Methods

In this randomized controlled trial conducted at 15 sites, 192 patients with Rutherford class 3-5 were randomly

SUBMITTER: Ni L 

PROVIDER: S-EPMC8982076 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature