Status:
COMPLETED
AcoArt III / Arterio-venous Fistula in China
Lead Sponsor:
Acotec Scientific Co., Ltd
Conditions:
Arteriovenous Fistula Stenosis
Eligibility:
All Genders
18-85 years
Phase:
NA
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 stud...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2022
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT03366727
Start Date
May 1 2018
End Date
July 7 2022
Last Update
July 27 2022
Active Locations (13)
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1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
2
Tongren hospital, Capital medical university
Beijing, Beijing Municipality, China
3
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
4
Guangdong provincial people's hospital
Guangzhou, Guangdong, China