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Percutaneous Less Invasive AV Fistula for Vascular Access in ESRD

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ClinicalTrials.gov Identifier: NCT02363972
Recruitment Status : Completed
First Posted : February 16, 2015
Results First Posted : September 9, 2020
Last Update Posted : November 9, 2021
Information provided by (Responsible Party):
Medtronic Endovascular

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease AV Fistula Fistula End Stage Kidney Disease Device: Ellipsys Vascular Access Catheter Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ellipsys Vascular Access Catheter System Clinical Trial
Actual Study Start Date : February 10, 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

  2. 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.

Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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

  6. 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

  7. 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

  8. 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

  9. Transposition Rate [ Time Frame: 90 days ]
    Percent of subjects who required one or more surgical transpositions performed to facilitate needle access

Other Outcome Measures:
  1. 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).

  2. 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.

  3. Target Vessel Location [ Time Frame: 90 days ]
    Anatomic location of matured target vessel

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02363972

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United States, Arizona
Southwest Vascular Center
Tempe, Arizona, United States, 85281
United States, California
BNMG San Diego Vascular Access Center
San Diego, California, United States, 92115
United States, Texas
Dallas Nephrology Associates
Plano, Texas, United States, 75093
San Antonio Kidney Disease Center
San Antonio, Texas, United States, 78016
United States, Virginia
Richmond Vascular Center
North Chesterfield, Virginia, United States, 23236
Sponsors and Collaborators
Medtronic Endovascular
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Principal Investigator: Jeffrey Hull, MD Richmond Vascular Center
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Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT02363972    
Other Study ID Numbers: 01-0014-01
First Posted: February 16, 2015    Key Record Dates
Results First Posted: September 9, 2020
Last Update Posted: November 9, 2021
Last Verified: November 2021
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Arteriovenous Fistula
Urologic Diseases
Pathological Conditions, Anatomical
Renal Insufficiency, Chronic
Renal Insufficiency
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities