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This trial is aimed to evaluate the safety and efficacy of DCB in treating AVF stenosis in chinese population.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DCB group | Experimental | this group treated with drug coated balloon catheter, Orchid |
|
| PTA group | Experimental | this group treated with plain balloon catheter, Admiral Xtreme |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| drug-coated balloon catheter (Orchid, Acotec) | Device | After predilation, using drug-coated balloon catheter to cover the whole treated segment |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wei Guo | Chinese PLA General Hospital | Principal Investigator |
| Lan Zhang | RenJi Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Beijing | Beijing Municipality | China | |||
| Tongren hospital, Capital medical university |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38191561 | Derived | 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. |
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one arm treated with drug-coated balloon catheter, the other arm treated with plain balloon catheter
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| plain balloon catheter (Admiral, medtronic) | Device | After predilation, using plain balloon catheter to cover the whole treated segment |
|
| number of reinterventions | number of reinterventions in 12 months | 12 months |
| device success | Successful delivery to the target lesion, deployment, and retrieval at index procedure | during the procedure |
| clinical success | The resumption of dialysis for at least one session after the index procedure | 5 days |
| Procedural Success | residual stenosis≤30% and absence of SAE during perioperative period | 2 weeks |
| 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 |