Back to resultsAcoArt III / Arterio-venous Fistula in China
Primary Purpose
Arteriovenous Fistula Stenosis
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
drug-coated balloon catheter （Orchid, Acotec）
plain balloon catheter (Admiral, medtronic)
Sponsored by
About this trial
This is an interventional treatment trial for Arteriovenous Fistula Stenosis focused on measuring drug eluting balloon
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
Sites / Locations
- Chinese PLA General Hospital
- Tongren hospital, Capital medical university
- The First Affiliated Hospital of Chongqing Medical University
- Guangdong provincial people's hospital
- Nanfang hospital
- The first hospital of Hebei medical university
- The first hospital of Chinese medical university
- The First Affiliated Hospital of Zhengzhou University
- The first hospital of Jilin medical university
- Renji Hospital ShangHai Jiaotong University School Of Medicine
- Shaoyifu hospital, zhejiang medical universiyt
- Zhejiang provincial people's hospital
- Beijing Friendship Hospital,Capital Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
DCB group
PTA group
Arm Description
this group treated with drug coated balloon catheter, Orchid
this group treated with plain balloon catheter, Admiral Xtreme
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
number of reinterventions
number of reinterventions in 12 months
device success
Successful delivery to the target lesion, deployment, and retrieval at index procedure
clinical success
The resumption of dialysis for at least one session after the index procedure
Procedural Success
residual stenosis≤30% and absence of SAE during perioperative period
Full Information
NCT ID
NCT03366727
First Posted
October 27, 2017
Last Updated
July 25, 2022
Sponsor
Acotec Scientific Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT03366727
Brief Title
AcoArt III / Arterio-venous Fistula in China
Official Title
Drug-eluting Balloon for Arteriovenous Fistula in China
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
July 7, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acotec Scientific Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arteriovenous Fistula Stenosis
Keywords
drug eluting balloon
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
one arm treated with drug-coated balloon catheter, the other arm treated with plain balloon catheter
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
244 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DCB group
Arm Type
Experimental
Arm Description
this group treated with drug coated balloon catheter, Orchid
Arm Title
PTA group
Arm Type
Experimental
Arm Description
this group treated with plain balloon catheter, Admiral Xtreme
Intervention Type
Device
Intervention Name(s)
drug-coated balloon catheter （Orchid, Acotec）
Intervention Description
After predilation, using drug-coated balloon catheter to cover the whole treated segment
Intervention Type
Device
Intervention Name(s)
plain balloon catheter (Admiral, medtronic)
Intervention Description
After predilation, using plain balloon catheter to cover the whole treated segment
Primary Outcome Measure Information:
Title
primary patency of target lesion in 6 months
Description
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
Secondary Outcome Measure Information:
Title
primary patency of target lesion in 12 months
Description
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
Title
number of reinterventions
Description
number of reinterventions in 12 months
Time Frame
12 months
Title
device success
Description
Successful delivery to the target lesion, deployment, and retrieval at index procedure
Time Frame
during the procedure
Title
clinical success
Description
The resumption of dialysis for at least one session after the index procedure
Time Frame
5 days
Title
Procedural Success
Description
residual stenosis≤30% and absence of SAE during perioperative period
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Guo
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lan Zhang
Organizational Affiliation
RenJi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Tongren hospital, Capital medical university
City
Beijing
State/Province
Beijing
Country
China
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
Country
China
Facility Name
Guangdong provincial people's hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Nanfang hospital
City
Guangzhou
State/Province
Guangzhou
Country
China
Facility Name
The first hospital of Hebei medical university
City
Shijiangzhuang
State/Province
Hebei
Country
China
Facility Name
The first hospital of Chinese medical university
City
Harbin
State/Province
Heilongjiang
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
The first hospital of Jilin medical university
City
Changchun
State/Province
Jilin
Country
China
Facility Name
Renji Hospital ShangHai Jiaotong University School Of Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Shaoyifu hospital, zhejiang medical universiyt
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Zhejiang provincial people's hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Beijing Friendship Hospital,Capital Medical University
City
Beijing
Country
China
12. IPD Sharing Statement
Learn more about this trial
AcoArt III / Arterio-venous Fistula in China
We'll reach out to this number within 24 hrs