Arteriovenous Fistula Stenosis
Conditions
Keywords
drug eluting balloon
Brief summary
This trial is aimed to evaluate the safety and efficacy of DCB in treating AVF stenosis in chinese population.
Detailed description
For years, first-line treatment of AVFs stenoses has been percutaneous transluminal angioplasty. However, restenosis and reintervention rates remain incredibly high and occur, according to recent studies, in up to 60% and 70% of patients at 6 and 12 months, respectively. 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 and drug-coated balloons,therefore, it represents an attractive option for AVF stenoses.
Interventions
DEVICEdrug-coated balloon catheter （Orchid, Acotec）
After predilation, using drug-coated balloon catheter to cover the whole treated segment
DEVICEplain balloon catheter (Admiral, medtronic)
After predilation, using plain balloon catheter to cover the whole treated segment
Sponsors
Acotec Scientific Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
one arm treated with drug-coated balloon catheter, the other arm treated with plain balloon catheter
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)thrombus formation in target lesion; 3) surgical removal of target lesion;4) AVF was abandoned because of the target lesion could not be retreated |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| primary patency of target lesion in 12 months | 12 months | Primary Patency is defined as the freedom of reintervention for the target lesion,including: 1)clinical driven target lesion reintervention;2)thrombus formation in target lesion; 3) surgical removal of target lesion;4) AVF was abandoned because of the target lesion could not be retreated |
| number of reinterventions | 12 months | number of reinterventions in 12 months |
| device success | during the procedure | Successful delivery to the target lesion, deployment, and retrieval at index procedure |
| clinical success | 5 days | The resumption of dialysis for at least one session after the index procedure |
| Procedural Success | 2 weeks | residual stenosis≤30% and absence of SAE during perioperative period |
Countries
China
Outcome results
None listed