Drug-coated balloons delivering paclitaxel at the angioplasty site have proved their superiority in the treatment of coronary and peripheral arterial stenoses. Paclitaxel reduces neointimal hyperplasia, therefore, it represents an attractive option for AVF stenoses. This trial is aimed to evaluate the safety and efficacy of Peripheral scoring drug balloon (Dissolve AV) or Balloon Dilatation catheter ( Armada 35) in treating AVF stenosis in chinese population.
This is a prospective, multi-center, randomized controlled, open-label, superiority study. A total of 220 subjects will be enrolled from 11 sites in China. All subjects enrolled will be randomly assigned to the test group (Dissolve AV group, n=110) and the control group (Armada 35 group, n=110) with randomized allocation ratio of 1:1. Subjects in the test group and the control group will be treated with Peripheral scoring drug balloon or Balloon Dilatation catheter
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
220
Subjects in the test group will be treated with peripheral scoring drug balloon.
Subjects in the test group will be treated with plain balloon catheter.
Emergency general hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Tongren hospital, Capital medical university
Beijing, Beijing Municipality, China
Target lesion primary patency (TLPP) at 6 months post-procedure
TLPP ends with postoperative target lesion (including 5 mm proximal and 5 mm distal to the target lesion) failure (TLF) or target lesion-associated vascular access thrombosis. TLF is defined as the presence of at least one clinical symptom of inadequate dialysis blood flow (as defined in the NKF-K/DOQI guidelines) due to stenosis of the target lesion (≥ 50% stenosis of the target lesion on imaging), including significantly elevated venous pressure during dialysis, abnormal physical examination findings, and a decrease in pump-controlled blood flow.
Time frame: 6 month post-procedure
Target lesion primary patency (TLPP) at 12 months post-procedure
TLPP ends with postoperative target lesion (including 5 mm proximal and 5 mm distal to the target lesion) failure (TLF) or target lesion-associated vascular access thrombosis. TLF is defined as the presence of at least one clinical symptom of inadequate dialysis blood flow (as defined in the NKF-K/DOQI guidelines) due to stenosis of the target lesion (≥ 50% stenosis of the target lesion on imaging), including significantly elevated venous pressure during dialysis, abnormal physical examination findings, and a decrease in pump-controlled blood flow.
Time frame: 12 Month post-procedure
Device success
When evaluated with a single balloon dilatation catheter, it is defined as successful reach of a target lesion, dilatation without rupture, and successful withdrawal.
Time frame: 0 day post-procedure
Procedural Success
It is defined as ≤ 30% residual stenosis of the target lesion, and the absence of serious perioperative adverse events.
Time frame: 0 day post-procedure
Clinical success
At least one session of successful hemodialysis following the procedure.
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The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
ShuGuang Hospital affiliated to Shanghai University of Traditional Chinese
Shanghai, Shanghai Municipality, China
Huashan hospital affiliated to FuDan university
Shanghai, Shanghai Municipality, China
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
Taiyuan Central Hospital
Taiyuan, Shanxi, China
Shaoyifu hospital, zhejiang medical universiyt
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
Time frame: 0 - 5 days post-procedure