AcoArt III / Arterio-venous Fistula in China
Drug-eluting Balloon for Arteriovenous Fistula in China
1 other identifier
interventional
244
1 country
13
Brief Summary
This trial is aimed to evaluate the safety and efficacy of DCB in treating AVF stenosis in chinese population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2018
Longer than P75 for not_applicable
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2017
CompletedFirst Posted
Study publicly available on registry
December 8, 2017
CompletedStudy Start
First participant enrolled
May 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 7, 2022
CompletedJuly 27, 2022
July 1, 2022
3.1 years
October 27, 2017
July 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
6 months
Secondary Outcomes (5)
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
Study Arms (2)
DCB group
EXPERIMENTALthis group treated with drug coated balloon catheter, Orchid
PTA group
EXPERIMENTALthis group treated with plain balloon catheter, Admiral Xtreme
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
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
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
Shaoyifu hospital, zhejiang medical universiyt
Hangzhou, Zhejiang, China
Zhejiang provincial people's hospital
Hangzhou, Zhejiang, China
Beijing Friendship Hospital,Capital Medical University
Beijing, China
Related Publications (1)
Zhao Y, Wang P, Wang Y, Zhang L, Zhao Y, Li H, He Q, Liu H, Luo J, Jia X, Yu Z, Guo W, Zhang L. Drug-Coated Balloon Angioplasty for Dysfunctional Arteriovenous Hemodialysis Fistulae: A Randomized Controlled Trial. Clin J Am Soc Nephrol. 2024 Mar 1;19(3):336-344. doi: 10.2215/CJN.0000000000000359. Epub 2023 Dec 18.
PMID: 38191561DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Wei Guo
Chinese PLA General Hospital
- PRINCIPAL INVESTIGATOR
Lan Zhang
RenJi Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2017
First Posted
December 8, 2017
Study Start
May 1, 2018
Primary Completion
June 1, 2021
Study Completion
July 7, 2022
Last Updated
July 27, 2022
Record last verified: 2022-07