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Catheter System Feasibility Clinical Trial

Primary Purpose

Renal Insufficiency, Chronic

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Percutaneous creation of an arteriovenous fistula
Sponsored by
Medtronic Endovascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Insufficiency, Chronic

Eligibility Criteria

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

Inclusion Criteria:

  • Patients deemed medically eligible for AV fistula creation per institutional guidelines and/or clinical judgment
  • Patients diagnosed with chronic kidney disease classification stage IV or V
  • Adequate quality vein >= 2 mm with confirmed clinically significant outflow based on pre-operative assessment
  • Adequate quality radial artery >= 2 mm based on pre-operative assessment
  • Adequate collateral arterial perfusion
  • Radial artery-adjacent vein proximity < = 1.5 mm
  • Able to provide informed consent
  • Able to travel to institution for follow up examination
  • Able to intraoperatively place an .014" guidewire in artery

Exclusion Criteria:

  • Suspected skin disease
  • Immunocompromised patients (e.g. HIV positive)
  • Edema of extremities
  • Current diagnosis of carcinoma
  • Pregnancy or currently breast feeding
  • Diagnosed hypercoaguable state
  • Active infection
  • Evidence of vascular disease at target site
  • Pre-existing vascular disease that could confound study results
  • Vessel tortuosity or spasm preventing placement of .014" guidewire

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Treatment

    Arm Description

    Interventional use of experimental Ellipsys catheter system for percutaneous creation of an arteriovenous fistula

    Outcomes

    Primary Outcome Measures

    Number of Participants With Sufficient Patency for Clinical Access
    Arteriovenous fistula is patent as determined by auscultation or ultrasound and eligible for maturation assistance to achieve clinical access flow rate.
    Number of Patients Achieving Dialysis Access
    Arteriovenous fistula is mature and patient has started dialysis using the fistula
    Number of Patients on Dialysis Using the Arteriovenous Fistula or Has Adequate Access Flow Rate to Allow Dialysis
    Arteriovenous fistula is mature or has achieved a minimum clinically acceptable access flow rate as determined by doppler ultrasound assessment to support dialysis

    Secondary Outcome Measures

    Number of Patients Requiring Additional Interventions to Achieve Maturation and Dialysis Access
    The number of patients requiring additional interventions to achieve maturation and initiation of dialysis.

    Full Information

    First Posted
    June 23, 2016
    Last Updated
    February 3, 2021
    Sponsor
    Medtronic Endovascular
    Collaborators
    Hospital Universitario Dr. Jose E. Gonzalez
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02816398
    Brief Title
    Catheter System Feasibility Clinical Trial
    Official Title
    Vessel-Select Catheter System Feasibility Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    October 2015 (Actual)
    Study Completion Date
    January 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Medtronic Endovascular
    Collaborators
    Hospital Universitario Dr. Jose E. Gonzalez

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Feasibility clinical study to evaluate the safety and effectiveness of the catheter system for the percutaneous creation of an arteriovenous fistula for patients with end stage renal disease requiring dialysis access.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Renal Insufficiency, Chronic

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment
    Arm Type
    Experimental
    Arm Description
    Interventional use of experimental Ellipsys catheter system for percutaneous creation of an arteriovenous fistula
    Intervention Type
    Device
    Intervention Name(s)
    Percutaneous creation of an arteriovenous fistula
    Intervention Description
    Use of catheter system for percutaneous creation of an arteriovenous fistula
    Primary Outcome Measure Information:
    Title
    Number of Participants With Sufficient Patency for Clinical Access
    Description
    Arteriovenous fistula is patent as determined by auscultation or ultrasound and eligible for maturation assistance to achieve clinical access flow rate.
    Time Frame
    6 weeks
    Title
    Number of Patients Achieving Dialysis Access
    Description
    Arteriovenous fistula is mature and patient has started dialysis using the fistula
    Time Frame
    6 weeks
    Title
    Number of Patients on Dialysis Using the Arteriovenous Fistula or Has Adequate Access Flow Rate to Allow Dialysis
    Description
    Arteriovenous fistula is mature or has achieved a minimum clinically acceptable access flow rate as determined by doppler ultrasound assessment to support dialysis
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Number of Patients Requiring Additional Interventions to Achieve Maturation and Dialysis Access
    Description
    The number of patients requiring additional interventions to achieve maturation and initiation of dialysis.
    Time Frame
    12 weeks

    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: Patients deemed medically eligible for AV fistula creation per institutional guidelines and/or clinical judgment Patients diagnosed with chronic kidney disease classification stage IV or V Adequate quality vein >= 2 mm with confirmed clinically significant outflow based on pre-operative assessment Adequate quality radial artery >= 2 mm based on pre-operative assessment Adequate collateral arterial perfusion Radial artery-adjacent vein proximity < = 1.5 mm Able to provide informed consent Able to travel to institution for follow up examination Able to intraoperatively place an .014" guidewire in artery Exclusion Criteria: Suspected skin disease Immunocompromised patients (e.g. HIV positive) Edema of extremities Current diagnosis of carcinoma Pregnancy or currently breast feeding Diagnosed hypercoaguable state Active infection Evidence of vascular disease at target site Pre-existing vascular disease that could confound study results Vessel tortuosity or spasm preventing placement of .014" guidewire

    12. IPD Sharing Statement

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    Catheter System Feasibility Clinical Trial

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