This trial is aimed to evaluate the safety and efficacy of DCB in treating AVF stenosis in chinese population.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
244
After predilation, using drug-coated balloon catheter to cover the whole treated segment
After predilation, using plain balloon catheter to cover the whole treated segment
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Tongren hospital, Capital medical university
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
primary patency of target lesion in 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
Time frame: 6 months
primary patency of target lesion in 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
Time frame: 12 months
number of reinterventions
number of reinterventions in 12 months
Time frame: 12 months
device success
Successful delivery to the target lesion, deployment, and retrieval at index procedure
Time frame: during the procedure
clinical success
The resumption of dialysis for at least one session after the index procedure
Time frame: 5 days
Procedural Success
residual stenosis≤30% and absence of SAE during perioperative period
Time frame: 2 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Chongqing, Chongqing Municipality, China
Guangdong provincial people's hospital
Guangzhou, Guangdong, China
Nanfang hospital
Guangzhou, Guangzhou, China
The first hospital of Hebei medical university
Shijiangzhuang, Hebei, China
The first hospital of Chinese medical university
Harbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
The first hospital of Jilin medical university
Changchun, Jilin, China
Renji Hospital ShangHai Jiaotong University School Of Medicine
Shanghai, Shanghai Municipality, China
...and 3 more locations