Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
143 participants
INTERVENTIONAL
2021-12-31
2023-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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DCB Treatment Group
Subjects treated with DCB
Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
After predilation, using drug-coated balloon catheter to cover the whole treated segment
Interventions
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Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
After predilation, using drug-coated balloon catheter to cover the whole treated segment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Arteriovenous fistula is matured and has undergone one or more hemodialysis sessions
* Venous stenosis of the AV fistula
* target lesion has stenosis ≥50% evidenced by angiography. and have at least one symptom of these：1,the venous pressure increased significantly during dialysis. 2,abnormal physical examination. 3,Decrease in blood flow
* the length of target lesion ≤100mm
* Patient able to give informed consent
* residual stenosis ≤30% after predilation
Exclusion Criteria
* AVF located at lower limbs
* Two or more than two stenosis at the target vessel.
* Obstruction of central venous return
* ISR
* AVF with acute thrombosis requiring lysis or thrombectomy in 30 days
* Vascular access has surgery in 30 days or intending to undergo a surgery
* Known hypersensitivity to aspirin, heparin, clopidogrel,paclitaxel, contrast medium, etc.
* Patients undergoing immunotherapy or suspected / confirmed vasculitis
* Patients with history of blood coagulation dysfunction and history of thrombocytopenic purpura
* Vascular access infection or systemic active infection
* Patients's life expectancy is less than 12 months
* Renal transplantation has been planned or converted to peritoneal dialysis
* Other medical conditions that lead to researchers who believe that patients may not be able to follow the trial program
* Involved in other drugs, biology, medical device research, or has been involved in other similar products clinical Test
18 Years
85 Years
ALL
No
Sponsors
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Zhejiang Zylox Medical Device Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Lan Zhang
Role: PRINCIPAL_INVESTIGATOR
RenJi Hospital
Central Contacts
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Other Identifiers
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V1.0
Identifier Type: -
Identifier Source: org_study_id