Clinical trial NCT03366727: AcoArt III / Arterio-venous Fistula in China
Official title: Drug-eluting Balloon for Arteriovenous Fistula in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arteriovenous Fistula Stenosis
Keywords: drug eluting balloon
Lead sponsor: Acotec Scientific Co., Ltd
Sponsor class: INDUSTRY
First posted: 2017-12-08
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: one arm treated with drug-coated balloon catheter, the other arm treated with plain balloon catheter
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: primary patency of target lesion in 6 months
timeFrame: 6 months
Secondary outcomes:
measure: primary patency of target lesion in 12 months
timeFrame: 12 months
measure: number of reinterventions
timeFrame: 12 months
measure: device success
timeFrame: during the procedure
measure: clinical success
timeFrame: 5 days
measure: Procedural Success
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Beijing
country: China
facility: Tongren hospital, Capital medical university
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Guangzhou
country: China
facility: Guangdong provincial people's hospital
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang hospital
state: Guangzhou
city: Shijiangzhuang
country: China
facility: The first hospital of Hebei medical university
state: Hebei
city: Harbin
country: China
facility: The first hospital of Chinese medical university
state: Heilongjiang
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Changchun
country: China
facility: The first hospital of Jilin medical university
state: Jilin
city: Shanghai
country: China
facility: Renji Hospital ShangHai Jiaotong University School Of Medicine
state: Shanghai
city: Hangzhou
country: China
facility: Shaoyifu hospital, zhejiang medical universiyt
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang provincial people's hospital
state: Zhejiang
city: Beijing
country: China
facility: Beijing Friendship Hospital,Capital Medical University
Study officials:
affiliation: Chinese PLA General Hospital
name: Wei Guo
role: PRINCIPAL_INVESTIGATOR
affiliation: RenJi Hospital
name: Lan Zhang
role: PRINCIPAL_INVESTIGATOR
References: