Drug-eluting PTA Balloon Dilatation Catheter in the Treatment of Peripheral Artery Stenosis or Occlusion

Safety and Efficacy of ZENFlow™ Drug-eluting PTA Balloon Dilatation Catheter in the Treatment of Iliac, Femoral and Popliteal Artery Stenosis or Occlusion

Clinical study on safety and efficacy of ZENFlow™ drug-eluting PTA balloon dilatation catheter in the treatment of iliac, femoral and popliteal artery stenosis or occlusion

The purpose of this study was to evaluate the safety and efficacy of ZENFlow™ drug-eluting PTA balloon dilatation catheter (paclitaxel 3±1 μg/mm2 balloon surface area) in the treatment of iliac artery, femoral artery and popliteal stenosis or occlusive lesions compared with conventional PTA balloon dilatation catheter.

Inclusion Criteria:

• Aged from 18 to 85 years old, male or female
• Subject's target lesions were stenosis and/or occlusion
• Subjects were able to understand the purpose of the study, demonstrate full compliance with the program and sign informed consent

Exclusion Criteria:

• Pregnant woman or who's pregnancy test is positive
• Lactation period woman or woman/man with fertility plan