To evaluate the safety and efficacy of the Zylox Drug Coated Balloon (DCB) for treatment of subjects presenting with de novo or non-stented restenotic obstructive lesion of native arteriovenous dialysis fistulae (AVF) in the upper extremity in China.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
143
After predilation, using drug-coated balloon catheter to cover the whole treated segment
primary patency of target lesion in 6 months
Primary Patency is defined as the freedom of reintervention for the target lesion,including: 1)clinical driven target lesion reintervention; 2) PSVR\< 2.4
Time frame: 6 months
Device Success
Successful delivery to the target lesion, deployment, and retrieval at index procedure
Time frame: Time of procedure
Clinical Success
The resumption of dialysis for at least one session after the index procedure
Time frame: From the time of the index procedure to the first successful dialysis session after index procedure. Typically, this is within 1 week of index procedure.
Procedural Success
Maintenance of patency (≤30% residual stenosis) in the absence of peri-procedural serious adverse device effect (SADE).
Time frame: 2 weeks
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