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Paclitaxel-Coated Balloon for the Treatment of AVF (AVF)

Primary Purpose

Arteriovenous Fistula

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
Sponsored by
Zhejiang Zylox Medical Device Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arteriovenous Fistula focused on measuring DCB

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    DCB Treatment Group

    Arm Description

    Subjects treated with DCB

    Outcomes

    Primary Outcome Measures

    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) PSVR< 2.4

    Secondary Outcome Measures

    Device Success
    Successful delivery to the target lesion, deployment, and retrieval at index procedure
    Clinical Success
    The resumption of dialysis for at least one session after the index procedure
    Procedural Success
    Maintenance of patency (≤30% residual stenosis) in the absence of peri-procedural serious adverse device effect (SADE).

    Full Information

    First Posted
    September 20, 2021
    Last Updated
    October 7, 2021
    Sponsor
    Zhejiang Zylox Medical Device Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05088083
    Brief Title
    Paclitaxel-Coated Balloon for the Treatment of AVF
    Acronym
    AVF
    Official Title
    Single-arm Study of Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon for the Treatment of Obstructive Lesions in the Native Arteriovenous Dialysis Fistulae (AVF)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2021 (Anticipated)
    Primary Completion Date
    March 2023 (Anticipated)
    Study Completion Date
    September 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Zhejiang Zylox Medical Device Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    To evaluate the safety and efficacy of the Zylox Drug Coated Balloon (DCB) for treatment of subjects presenting with de novo or non-stented restenotic obstructive lesion of native arteriovenous dialysis fistulae (AVF) in the upper extremity in China.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Arteriovenous Fistula
    Keywords
    DCB

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    143 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    DCB Treatment Group
    Arm Type
    Experimental
    Arm Description
    Subjects treated with DCB
    Intervention Type
    Device
    Intervention Name(s)
    Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
    Other Intervention Name(s)
    Zylox
    Intervention Description
    After predilation, using drug-coated balloon catheter to cover the whole treated segment
    Primary Outcome Measure Information:
    Title
    primary patency of target lesion in 6 months
    Description
    Primary Patency is defined as the freedom of reintervention for the target lesion,including: 1)clinical driven target lesion reintervention; 2) PSVR< 2.4
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Device Success
    Description
    Successful delivery to the target lesion, deployment, and retrieval at index procedure
    Time Frame
    Time of procedure
    Title
    Clinical Success
    Description
    The resumption of dialysis for at least one session after the index procedure
    Time Frame
    From the time of the index procedure to the first successful dialysis session after index procedure. Typically, this is within 1 week of index procedure.
    Title
    Procedural Success
    Description
    Maintenance of patency (≤30% residual stenosis) in the absence of peri-procedural serious adverse device effect (SADE).
    Time Frame
    2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jie Liang, Bachelor
    Phone
    13819565660
    Email
    jie.liang@zyloxmedical.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lan Zhang
    Organizational Affiliation
    RenJi Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Paclitaxel-Coated Balloon for the Treatment of AVF

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