A Safety and Efficacy Study of Hemodialysis Arteriovenous Fistulae Stenosis Treated With DissolveAV (DissolveAVF)

Evaluation of the Safety and Efficacy of the Peripheral Scoring Drug Balloon (Dissolve AV) in Treatment of Hemodialysis Arteriovenous Fistulae Stenosis A Prospective Multicenter Randomized Controlled Clinical Study

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, therefore, it represents an attractive option for AVF stenoses. This trial is aimed to evaluate the safety and efficacy of Peripheral scoring drug balloon (Dissolve AV) or Balloon Dilatation catheter ( Armada 35) in treating AVF stenosis in chinese population.

Study Overview

• Status: Completed
• Conditions: Fistulas Arteriovenous
• Intervention / Treatment: Device: Dissolve AVF; Device: Armada 35

Detailed Description

This is a prospective, multi-center, randomized controlled, open-label, superiority study. A total of 220 subjects will be enrolled from 10 sites in China. All subjects enrolled will be randomly assigned to the test group (Dissolve AV group, n=110) and the control group (Armada 35 group, n=110) with randomized allocation ratio of 1:1. Subjects in the test group and the control group will be treated with Peripheral scoring drug balloon or Balloon Dilatation catheter

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Peking Union Medical College Hospital
    • Beijing, Beijing, China
      • Tongren hospital, Capital medical university
    • Beijing, Beijing, China
      • Emergency General Hospital
  • Chongqing
    • Chongqing, Chongqing, China
      • The First Affiliated Hospital of Chongqing Medical University
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • ShuGuang Hospital affiliated to Shanghai University of Traditional Chinese
    • Shanghai, Shanghai, China
      • Huashan Hospital affiliated to Fudan University
    • Shanghai, Shanghai, China
      • Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine
  • Shanxi
    • Taiyuan, Shanxi, China
      • Taiyuan Central Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Shaoyifu hospital, zhejiang medical universiyt
    • Hangzhou, Zhejiang, China
      • The First Affiliated Hospital of Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years and ≤ 75 years, male or female.
• Arteriovenous fistula or Arteriovenous graft is matured and has undergone one or more hemodialysis sessions
• Venous stenosis of the AV fistula or AV graft
• target lesion has stenosis ≥50% evidenced by angiography. and have at least one symptom of these：1.Venous pressure increased significantly during dialysis,2.Abnomal phenomenon physical examination,3.Decrease in pumping blood flow.
• Target lesion consists of a single lesion or a multiple lesions with target lesion length ≤ 40 mm. Reference vessel diameter of target lesion ≥ 4.0 mm and ≤ 7.0 mm.
• If patient has non-target lesion, the stenosis ≥50% and don't need to be treated.
• Patient able to give informed consent

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: Dissolve AVF Group; This group treated with Peripheral scoring drug balloon.Dissolve AVF	Device: Dissolve AVF; Subjects in the test group will be treated with peripheral scoring drug balloon.; Other Names: Using Peripheral scoring drug balloon catheter to cover the whole treated segment
Active Comparator: PTA Group; This group treated with plain balloon catheter.Armada 35	Device: Armada 35; Subjects in the test group will be treated with plain balloon catheter.; Other Names: 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 rate of the target lesion at 6 month post procedure [ Target Lesion Primary Patency ]	Target Lesion Primary Patency is defined as Target Lesion((+/-5mm proximal or distal of the target lesion)) failure(TLF) or target Vasculal Access Thrombosis. TLF is defined as target lesion stenosis(Stenosis rate>30% by Digital Substraction Angiography(DSA)) result in insufficient hemodialysis flow (Refer to NKF-K/DOQIguideline) including: Venous pressure increased significantly during dialysis /Abnomal phenomenon physical examination/Decrease in pumping blood flow.	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary patency of target lesion in 12 months	Target Lesion Primary Patency is defined as Target Lesion((+/-5mm proximal or distal of the target lesion)) failure(TLF) or target Vasculal Access Thrombosis. TLF is defined as target lesion stenosis(Stenosis rate >30% by Digital Substraction Angiography(DSA)) result in insufficient hemodialysis flow (Refer to NKF-K/DOQIguideline)including: Venous pressure increased significantly during dialysis /Abnomal phenomenon physical examination/Decrease in pumping blood flow.	12 Month
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 perio	2 weeks

Collaborators and Investigators

• Sponsor: DK Medical Technology (Suzhou) Co., Ltd.
• Investigators: Study Chair: YE CHAOYANG, ShuGuang Hospital affiliated to Shanghai University of Traditional Chinese

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2019
• Primary Completion (Actual): October 2, 2021
• Study Completion (Actual): January 4, 2022

Study Registration Dates

• First Submitted: January 7, 2020
• First Submitted That Met QC Criteria: January 10, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 17, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Dialysis scoring Fistulas
• 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: VP-P-2018-018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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