AcoArt III / Arterio-venous Fistula in China

Not Applicable

Completed

• Conditions: Arteriovenous Fistula Stenosis

• Registration Number: NCT03366727
• Lead Sponsor: Acotec Scientific Co., Ltd

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.

Study Timeline

• Study First Submitted: 2017-10-27
• Study First Submitted QC: 2017-12-04
• Study First Posted: 2017-12-08
• Study Start: 2018-05-01
• Primary Completion: 2021-06-01
• Status Verified: 2022-07
• Study Completion: 2022-07-07
• Last Update Submitted: 2022-07-25
• Last Update Posted: 2022-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 244

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (13)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China

Tongren hospital, Capital medical university; 🇨🇳 Beijing, Beijing, China

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, 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, China

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