A Trail of Drug-coated Balloon Treating Below The Knee Arterial Diseases

A Prospective, Multicenter, Randomized Controlled Trail Using Drug-coated Balloon to Treat Below The Knee Arterial Stenosis or Occlusion

This is a prospective, multicenter, randomized controlled trail using drug-coated balloon to treat below the knee arterial stenosis or occlusion.

This trail is conducted in several centers all around China. 202 subjects with below the knee arterial stenosis or occlusion will be recruited and randomized, this trail compares the efficacy and safety of Drug-coated Balloon (Zylox-Tonbridge) with a similar balloon catheter producted by Acotec. The subjects will be followed up when discharged /in 30 days/ 6 months.

Inclusion Criteria:

• Age 18-85 years；
• ≥70% diameter stenosis or occlusion in the target below-the-knee lesion；
• Rutherford Category 3-6；
• Subjects are willing to sign informed consent；

Exclusion Criteria:

• Planned major limb amputation within 30 days after the procedure;
• In-stent stenosis in the target lesion;
• Severely calcified target lesions；
• Creatinine>2.5mg/dL;
• History of allergies to anesthetics, contrast agents；
• Subjects who have participated in any other drug or medical device clinical investigations and haven't reach the primary endpoint；
• Other circumstances judged by researchers that are not suitable for enrollment.