AcoArt III / Arterio-venous Fistula in China

NCT ID: NCT03366727

Last Updated: 2022-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 244 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2022-07-07

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.

Conditions

Arteriovenous Fistula Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

DCB group

this group treated with drug coated balloon catheter, Orchid

Group Type: EXPERIMENTAL

drug-coated balloon catheter （Orchid, Acotec）

Intervention Type: DEVICE

After predilation, using drug-coated balloon catheter to cover the whole treated segment

PTA group

this group treated with plain balloon catheter, Admiral Xtreme

Group Type: EXPERIMENTAL

plain balloon catheter (Admiral, medtronic)

Intervention Type: DEVICE

After predilation, using plain balloon catheter to cover the whole treated segment

Interventions

drug-coated balloon catheter （Orchid, Acotec）

After predilation, using drug-coated balloon catheter to cover the whole treated segment

Intervention Type: DEVICE

plain balloon catheter (Admiral, medtronic)

After predilation, using plain balloon catheter to cover the whole treated segment

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Acotec Scientific Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wei Guo

Role: PRINCIPAL_INVESTIGATOR

Chinese PLA General Hospital

Lan Zhang

Role: PRINCIPAL_INVESTIGATOR

RenJi Hospital

Locations

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Tongren hospital, Capital medical university

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

Countries

China

References

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.

Reference Type: DERIVED

PMID: 38191561 (View on PubMed)

Other Identifiers

Acotec-05

Identifier Type: -

Identifier Source: org_study_id