AcoArt III / Arterio-venous Fistula in China
- Conditions
- Arteriovenous Fistula Stenosis
- Interventions
- Device: drug-coated balloon catheter （Orchid, Acotec）Device: plain balloon catheter (Admiral, medtronic)
- Registration Number
- NCT03366727
- Lead Sponsor
- Acotec Scientific Co., Ltd
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 244
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DCB group drug-coated balloon catheter （Orchid, Acotec） this group treated with drug coated balloon catheter, Orchid PTA group plain balloon catheter (Admiral, medtronic) this group treated with plain balloon catheter, Admiral Xtreme
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (13)
The first hospital of Jilin medical university
🇨🇳Changchun, Jilin, China
Beijing Friendship Hospital,Capital Medical University
🇨🇳Beijing, China
Tongren hospital, Capital medical university
🇨🇳Beijing, Beijing, China
Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China
Nanfang hospital
🇨🇳Guangzhou, Guangzhou, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Renji Hospital ShangHai Jiaotong University School Of Medicine
🇨🇳Shanghai, Shanghai, China
Shaoyifu hospital, zhejiang medical universiyt
🇨🇳Hangzhou, Zhejiang, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
Guangdong provincial people's hospital
🇨🇳Guangzhou, Guangdong, China
The first hospital of Hebei medical university
🇨🇳Shijiangzhuang, Hebei, China
The first hospital of Chinese medical university
🇨🇳Harbin, Heilongjiang, China
Zhejiang provincial people's hospital
🇨🇳Hangzhou, Zhejiang, China