Percutaneous Less Invasive AV Fistula for Vascular Access in ESRD

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: Completed
• Conditions: End Stage Renal Disease; Fistula; End Stage Kidney Disease; AV Fistula
• Intervention / Treatment: Device: Ellipsys Vascular Access Catheter

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maturation Success Rate at 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	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

Outcome Measure	Measure Description	Time Frame
Percent of Participants With Access Systems That Successfully Created an AVF	Percent of Ellipsys Vascular Access Systems that successfully created an AVF upon deployment	90 days
Percent of Access Sites With Clinical Patency at Discharge	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	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	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	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	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	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	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	Percent of subjects who required one or more surgical transpositions performed to facilitate needle access	90 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to First AVF Cannulation	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	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	Anatomic location of matured target vessel	90 days

Collaborators and Investigators

• Sponsor: Medtronic Endovascular

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 10, 2015
• Primary Completion (ACTUAL): June 1, 2016
• Study Completion (ACTUAL): June 1, 2016

Study Registration Dates

• First Submitted: February 6, 2015
• First Submitted That Met QC Criteria: February 10, 2015
• First Posted (ESTIMATE): February 16, 2015

Study Record Updates

• Last Update Posted (ACTUAL): November 9, 2021
• Last Update Submitted That Met QC Criteria: November 8, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Urologic Diseases; Congenital Abnormalities; Renal Insufficiency; Pathological Conditions, Anatomical; Renal Insufficiency, Chronic; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Kidney Diseases; Kidney Failure, Chronic; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: 01-0014-01