Arteriovenous Fistula
Conditions
Keywords
DCB
Brief summary
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.
Interventions
DEVICEPaclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
After predilation, using drug-coated balloon catheter to cover the whole treated segment
Sponsors
Zhejiang Zylox Medical Device Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Age during 18-85 years old * 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
* Women who are breastfeeding, pregnant or are intending to become pregnant * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| primary patency of target lesion in 6 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Success | Time of procedure | Successful delivery to the target lesion, deployment, and retrieval at index procedure |
| Clinical Success | 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. | The resumption of dialysis for at least one session after the index procedure |
| Procedural Success | 2 weeks | Maintenance of patency (≤30% residual stenosis) in the absence of peri-procedural serious adverse device effect (SADE). |
Contacts
Primary ContactJie Liang, Bachelor
Outcome results
None listed