Drug-eluting Balloon for Arteriovenous Fistula in China
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Acotec Scientific Co., Ltd
- Enrollment
- 244
- Locations
- 13
- Primary Endpoint
- primary patency of target lesion in 6 months
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •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
Outcomes
Primary Outcomes
primary patency of target lesion in 6 months
Time Frame: 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 Outcomes
- primary patency of target lesion in 12 months(12 months)
- number of reinterventions(12 months)
- device success(during the procedure)
- clinical success(5 days)
- Procedural Success(2 weeks)