AcoArt III / Arterio-venous Fistula in China
Study Details
Study Description
Brief Summary
This trial is aimed to evaluate the safety and efficacy of DCB in treating AVF stenosis in chinese population.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: DCB group this group treated with drug coated balloon catheter, Orchid |
Device: drug-coated balloon catheter （Orchid, Acotec）
After predilation, using drug-coated balloon catheter to cover the whole treated segment
|
| Experimental: PTA group this group treated with plain balloon catheter, Admiral Xtreme |
Device: plain balloon catheter (Admiral, medtronic)
After predilation, using plain balloon catheter to cover the whole treated segment
|
Outcome Measures
Primary Outcome Measures
- primary patency of target lesion in 6 months [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 [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 [12 months]
number of reinterventions in 12 months
- device success [during the procedure]
Successful delivery to the target lesion, deployment, and retrieval at index procedure
- clinical success [5 days]
The resumption of dialysis for at least one session after the index procedure
- Procedural Success [2 weeks]
residual stenosis≤30% and absence of SAE during perioperative period
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chinese PLA General Hospital | Beijing | Beijing | China | |
| 2 | Tongren hospital, Capital medical university | Beijing | Beijing | China | |
| 3 | The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing | China | |
| 4 | Guangdong provincial people's hospital | Guangzhou | Guangdong | China | |
| 5 | Nanfang hospital | Guangzhou | Guangzhou | China | |
| 6 | The first hospital of Hebei medical university | Shijiangzhuang | Hebei | China | |
| 7 | The first hospital of Chinese medical university | Harbin | Heilongjiang | China | |
| 8 | The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | China | |
| 9 | The first hospital of Jilin medical university | Changchun | Jilin | China | |
| 10 | Renji Hospital ShangHai Jiaotong University School Of Medicine | Shanghai | Shanghai | China | |
| 11 | Shaoyifu hospital, zhejiang medical universiyt | Hangzhou | Zhejiang | China | |
| 12 | Zhejiang provincial people's hospital | Hangzhou | Zhejiang | China | |
| 13 | Beijing Friendship Hospital,Capital Medical University | Beijing | China |
Sponsors and Collaborators
- Acotec Scientific Co., Ltd
Investigators
- Principal Investigator: Wei Guo, Chinese PLA General Hospital
- Principal Investigator: Lan Zhang, RenJi Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Acotec-05