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Rapamycin Coated Balloon Dilation Catheter for Arteriovenous Fistula

Primary Purpose

Peripheral Arterial Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rapamycin drug balloon angioplasty
Paclitaxel drug balloon angioplasty
Sponsored by
Shanghai Bomaian Medical Technology Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: AVF has been established, with mature development and at least one successful completion of hemodialysis； AVF has significant hemodynamic abnormalities； exclusion criteria The target lesion has undergone intervention treatment within 30 days； An intravascular stent has been placed at any location along the vascular pathway；

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Rapamycin coated balloon dilation catheter for arteriovenous fistula

    Paclitaxel release high-pressure shunt balloon dilation catheter

    Arm Description

    Experimental group rapamycin balloon therapy for autologous arteriovenous fistulas with stenosis or occlusion

    Strict or occluded autologous arteriovenous fistula treated with paclitaxel balloon therapy in the control group

    Outcomes

    Primary Outcome Measures

    6-month target lesion primary patency rate
    Primary patency is defined as puncture dialysis that can be used to meet the requirements of the dialysis prescription without intervention treatment after the target lesion surgery.

    Secondary Outcome Measures

    Device success rate
    The treatment device can be successfully transported, expanded, and withdrawn without any defects such as balloon rupture or loss of device integrity or design performance when expanded without exceeding the rated burst pressure.
    Surgical success rate
    The residual stenosis of the target lesion is ≤ 30%, and there are no adverse events related to the target dialysis pathway related to medical devices within 7 days after surgery/before discharge.
    Clinical success rate
    After the surgery, at least one puncture dialysis that meets the requirements of the dialysis prescription has been completed and no target pathway dysfunction has occurred before.

    Full Information

    First Posted
    August 24, 2023
    Last Updated
    August 31, 2023
    Sponsor
    Shanghai Bomaian Medical Technology Co., Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06029569
    Brief Title
    Rapamycin Coated Balloon Dilation Catheter for Arteriovenous Fistula
    Official Title
    Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Rapamycin Coated Balloon Dilation Catheter in the Treatment of Dialysis Pathway Stenosis or Blockage in Hemodialysis Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 15, 2023 (Anticipated)
    Primary Completion Date
    September 15, 2025 (Anticipated)
    Study Completion Date
    December 15, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shanghai Bomaian Medical Technology 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
    Verify the effectiveness and safety of rapamycin coated balloon dilation catheter for the treatment of dialysis pathway stenosis or blockage lesions.
    Detailed Description
    To verify the effectiveness and safety of the Rapamycin coated arteriovenous fistula balloon dilation catheter developed and produced by Shanghai Bomaian Medical Technology Co., Ltd. in the treatment of stenosis or blockage of the dialysis pathway of autologous arteriovenous fistula in hemodialysis patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peripheral Arterial Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    256 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Rapamycin coated balloon dilation catheter for arteriovenous fistula
    Arm Type
    Experimental
    Arm Description
    Experimental group rapamycin balloon therapy for autologous arteriovenous fistulas with stenosis or occlusion
    Arm Title
    Paclitaxel release high-pressure shunt balloon dilation catheter
    Arm Type
    Sham Comparator
    Arm Description
    Strict or occluded autologous arteriovenous fistula treated with paclitaxel balloon therapy in the control group
    Intervention Type
    Procedure
    Intervention Name(s)
    Rapamycin drug balloon angioplasty
    Intervention Description
    Rapamycin drug balloon treatment for stenosis or blockage of the dialysis pathway in autologous arteriovenous fistula.
    Intervention Type
    Procedure
    Intervention Name(s)
    Paclitaxel drug balloon angioplasty
    Intervention Description
    Paclitaxel drug balloon therapy for stenosis or blockage of the dialysis pathway of autologous arteriovenous fistula.
    Primary Outcome Measure Information:
    Title
    6-month target lesion primary patency rate
    Description
    Primary patency is defined as puncture dialysis that can be used to meet the requirements of the dialysis prescription without intervention treatment after the target lesion surgery.
    Time Frame
    6months
    Secondary Outcome Measure Information:
    Title
    Device success rate
    Description
    The treatment device can be successfully transported, expanded, and withdrawn without any defects such as balloon rupture or loss of device integrity or design performance when expanded without exceeding the rated burst pressure.
    Time Frame
    The day of operation.
    Title
    Surgical success rate
    Description
    The residual stenosis of the target lesion is ≤ 30%, and there are no adverse events related to the target dialysis pathway related to medical devices within 7 days after surgery/before discharge.
    Time Frame
    7Days
    Title
    Clinical success rate
    Description
    After the surgery, at least one puncture dialysis that meets the requirements of the dialysis prescription has been completed and no target pathway dysfunction has occurred before.
    Time Frame
    1year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: AVF has been established, with mature development and at least one successful completion of hemodialysis； AVF has significant hemodynamic abnormalities； exclusion criteria The target lesion has undergone intervention treatment within 30 days； An intravascular stent has been placed at any location along the vascular pathway；
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    qizhuang Jin
    Phone
    010-83572211
    Email
    jinqizhuang@bjmu.edu.cn

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Rapamycin Coated Balloon Dilation Catheter for Arteriovenous Fistula

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