Percutaneous Less Invasive AV Fistula for Vascular Access in ESRD

November 8, 2021 updated by: Medtronic Endovascular

Ellipsys Vascular Access Catheter System Clinical Trial

A prospective single-arm well-controlled study to evaluate the safety and effectiveness of a less invasive means of establishing vascular access to facilitate dialysis in patients with end stage renal disease.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
103

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tempe, Arizona, United States, 85281
        • Southwest Vascular Center
    • California
      • San Diego, California, United States, 92115
        • BNMG San Diego Vascular Access Center
    • Texas
      • Plano, Texas, United States, 75093
        • Dallas Nephrology Associates
      • San Antonio, Texas, United States, 78016
        • San Antonio Kidney Disease Center
    • Virginia
      • North Chesterfield, Virginia, United States, 23236
        • Richmond Vascular Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients were eligible for enrollment into the study if they met the following criteria:

  1. Patients ≥ 18 years of age and ≤ 80 years of age
  2. Male or non-pregnant female (verified with a urine/blood pregnancy test, for women of reproductive potential)
  3. Life expectancy of at least one year, per the investigator's opinion
  4. Diagnosed with end-stage renal disease (ESRD) or chronic kidney disease requiring dialysis or anticipated start of dialysis within 6 months of enrollment
  5. Patients deemed medically eligible for upper extremity autogenous AV fistula creation, per institutional guidelines and/or clinical judgment

  6. Adequate quality vein based on pre-operative assessment

    1. Adjacent vein diameter of ≥ 2.0 mm at target anastomosis site
    2. Confirmed clinically significant outflow

  7. Adequate quality radial artery based on pre-operative assessment

    a. Arterial lumen diameter of ≥ 2.0 mm at target anastomosis site

  8. Adequate collateral arterial perfusion

    1. Patent palmar arch
    2. Negative Allen's Test for ulnar artery insufficiency
  9. No clinical evidence of subclavian artery stenosis on the ipsilateral side.
  10. Radial artery-adjacent vein proximity ≤ 1.5 mm measured lumen edge-to-lumen edge as determined by pre-procedural ultrasound and confirmed pre-procedure
  11. Patient was able to provide written informed consent
  12. Able to travel to enrolling institution for follow-up examinations
  13. Able and willing to follow a daily aspirin and/or other anti-coagulation/antiplatelet regimen, not including warfarin (Coumadin, or comparable anti-coagulant, see exclusion criteria 15)

Exclusion Criteria:

Patients were excluded if any of the following was true:

  1. Documented or suspected central venous stenosis including upper extremity arterial stenosis (≥ 50%)
  2. a. Prior vascular surgery at or proximal (central) to the AVF target site b. Prior axillary dissection or mastectomy on the ipsilateral side as intended AV fistula site
  3. History of steal syndrome from a previous hemodialysis vascular access on the ipsilateral side which required intervention or abandonment
  4. Evidence of vascular disease at the radial artery/adjacent vein site on the ipsilateral side
  5. Pre-existing vascular disease that could confound the study results
  6. Systolic pressures < 100 mm Hg at the time of screening
  7. Suspected or confirmed skin disease at the skin entry site
  8. Immunocompromised patients (e.g. HIV positive)
  9. Edema of the upper extremity on the ipsilateral side
  10. Patients requiring immunosuppressant therapy such as sirolimus (Rapamune®) or Prednisone at a dose of > 10 mg per day
  11. Peripheral white blood cell count < 1.5 K/mm3 or platelet count < 75,000 cells/mm3
  12. Current diagnosis of carcinoma (defined as in remission < 1 year)
  13. Pregnant or currently breast feeding
  14. Known bleeding diathesis or coagulation disorder
  15. Receiving warfarin (Coumadin, or comparable anti-coagulant) therapy
  16. Patients with acute or active infection
  17. Scheduled kidney transplant within 6 months of enrollment
  18. Participation in another clinical investigation (excluding retrospective studies or studies not requiring a consent form)
  19. History of substance abuse or anticipated to be non-compliant with medical care or study requirements based on investigator judgment
  20. Patient required creation of an arteriovenous fistula distal to the wrist
  21. Patient required nerve block requiring immobilization of the arm

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Ellipsys Vascular Access Catheter
ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula.
Device: Ellipsys Vascular Access Catheter
A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maturation Success Rate at 90 Days
Time Frame: 90 days
Maturation success rate of the access site was a binary endpoint defined as (1) achievement of a venous diameter of greater than or equal to 4 mm and (2) blood flow greater than or equal to 500 ml/min as measured via duplex ultrasound at the 90 day follow-up visit for the ITT population.
90 days
Number of Participants With Device-related Serious Adverse Events
Time Frame: 90 days
The primary safety endpoint was defined as the percent of subjects having one or more of the following device-related serious adverse events: vessel perforation, vessel dissection, and electrical shock during index; and significant embolization in a previously uninvolved arterial territory within 90 days of the index procedure.
90 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent of Participants With Access Systems That Successfully Created an AVF
Time Frame: 90 days
Percent of Ellipsys Vascular Access Systems that successfully created an AVF upon deployment
90 days
Percent of Access Sites With Clinical Patency at Discharge
Time Frame: 90 days
Percent of access sites that demonstrated physical exam patency through clinic discharge
90 days
Percent of Access Sites That Sustain 2-needle Cannulation by 90 Days
Time Frame: 90 days
Percent of access sites that could sustain three 2-needle cannulations at the prescribed needle gauge and blood flow rate (Qb) between the 4 week and 90 day follow-up visits after initial AV fistula creation
90 days
Percent of Access Sites That Achieved or Maintained Maturation at 90 Days
Time Frame: 90 days
Percent of access sites which achieved or maintained maturation following intervening manipulations (surgical or endovascular) designed to promote or reestablish maturation. This definition also includes common definition for secondary patency.
90 days
Percent of Access Sites That Achieved Maturation Without Intervention
Time Frame: 90 days
Percent of access sites that achieved and maintained maturation without any surgical or endovascular intervention designed to promote or reestablish maturation
90 days
Percent of Access Sites That Were Patent Following Intervention
Time Frame: 90 days
Percent of access sites which were patent after intervening manipulations (surgical or endovascular) intended to promote or reestablish patency
90 days
Percent of Access Sites That Achieved Patency Without Intervention
Time Frame: 90 days
Percent of access sites that maintained patency without any surgical or endovascular intervention designed to maintain or reestablish blood flow in the access site
90 days
Intervention Rate
Time Frame: 90 days
Percent of subjects who had one or more surgical or endovascular interventions to maintain or reestablish blood flow in the access site
90 days
Transposition Rate
Time Frame: 90 days
Percent of subjects who required one or more surgical transpositions performed to facilitate needle access
90 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to First AVF Cannulation
Time Frame: 90 days
Time to AVF cannulation was defined as the elapsed time to the first use of access site (from the date of the study procedure).
90 days
Catheter Utilization
Time Frame: 90 days
Catheter utilization was defined as the total number of days a catheter was used before access site maturation per subject. The start date was either 1) the date of the study procedure, for subjects who already had a dialysis catheter in place or 2) the date placed, if during the study. The end date was either 1) the date the catheter was removed or 2) the 90 day visit, if the catheter was still in place.
90 days
Target Vessel Location
Time Frame: 90 days
Anatomic location of matured target vessel
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medtronic Endovascular

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 10, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2015

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 16, 2015

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 01-0014-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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