AcoArt III / Arterio-venous Fistula in China

Drug-eluting Balloon for Arteriovenous Fistula in China

This trial is aimed to evaluate the safety and efficacy of DCB in treating AVF stenosis in chinese population.

Study Overview

• Status: Completed
• Conditions: Arteriovenous Fistula Stenosis
• Intervention / Treatment: Device: drug-coated balloon catheter （Orchid, Acotec）; Device: plain balloon catheter (Admiral, medtronic)

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 Type: Interventional
• Enrollment (Actual): 244
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Friendship Hospital,Capital Medical University
  • Beijing
    • Beijing, Beijing, China
      • Chinese PLA General Hospital
    • Beijing, Beijing, China
      • Tongren hospital, Capital medical university
  • Chongqing
    • Chongqing, Chongqing, China
      • The First Affiliated Hospital of Chongqing Medical University
  • Guangdong
    • Guangzhou, Guangdong, China
      • Guangdong Provincial People's Hospital
  • Guangzhou
    • Guangzhou, Guangzhou, China
      • Nanfang Hospital
  • Hebei
    • Shijiangzhuang, Hebei, China
      • The First Hospital of Hebei Medical University
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • The First Hospital of Chinese Medical University
  • Henan
    • Zhengzhou, Henan, China
      • The First Affiliated Hospital of Zhengzhou University
  • Jilin
    • Changchun, Jilin, China
      • The first hospital of Jilin medical university
  • Shanghai
    • Shanghai, Shanghai, China
      • Renji Hospital Shanghai Jiaotong University School of Medicine
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Shaoyifu hospital, zhejiang medical universiyt
    • Hangzhou, Zhejiang, China
      • Zhejiang Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Acotec Scientific Co., Ltd
• Investigators: Principal Investigator: Wei Guo, Chinese PLA General Hospital; Principal Investigator: Lan Zhang, Renji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): July 7, 2022

Study Registration Dates

• First Submitted: October 27, 2017
• First Submitted That Met QC Criteria: December 4, 2017
• First Posted (Actual): December 8, 2017

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: drug eluting balloon
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: Acotec-05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No