Ellipsys Vascular Access System Registry

Ellipsys Vascular Access System Registry, Protocol 1.0. Version 1.0

Ellipsys Vascular Access System Registry will enroll up to 100 patients to evaluate the use and performance of the Ellipsys Vascular Access System when it is used within its intended use in accordance with standard of care in a clinical setting. The Ellipsys Vascular Access System is intended for use to create an arteriovenous (AV) fistula via percutaneous access.

Study Overview

• Status: Completed
• Conditions: End-stage Renal Disease
• Intervention / Treatment: Device: Ellipsys Vascular Access

Detailed Description

Ellipsys Vascular Access System Registry is a non-randomized, prospective, post-market, multi-center registry of the Ellipsys Vascular Access System in which up to 100 patients will be enrolled to evaluate the use and performance of the Ellipsys Vascular Access System when it is used within its intended use in accordance with standard of care in a clinical setting. The Ellipsys Vascular Access System is intended for use to create an AV fistula via percutaneous access. The primary performance endpoint is Clinical Success at the 90-day endpoint, where Clinical Success is defined as an access site that achieves a venous diameter of greater than or equal to 4 mm and blood flow greater than or equal to 500 ml/min in the brachial artery as measured via duplex ultrasound.

• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• Germany
  • Bad Krozingen, Germany, 79189
    • Universitäts-Herzzentrum Freiburg-Bad Krozingen
  • Dusseldorf, Germany
    • Universitätsklinikum Düsseldorf
  • Münster, Germany, 48149
    • Universitätsklinikum Münster
  • Saarbrücken, Germany, 66111
    • Universitatsklinikum des Saarlandes
  • Westerstede, Germany, 26655
    • Ammerland Klinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with End-Stage Renal Disease or chronic kidney disease who provide written informed consent; who are currently require dialysis or it is anticipated will need dialysis within six months of enrollment; who meet all inclusion criteria and none of the exclusion criteria; and who are considered eligible for enrollment.

Description

Inclusion Criteria:

• Diagnosed with End-Stage Renal Disease (ESRD) or chronic kidney disease requiring dialysis or anticipated start of dialysis within 6 months of enrollment.

• Patients deemed medically eligible for upper extremity autogenous AV fistula creation, per institutional guidelines and/or clinical judgment Adequate quality vein base on pre-operative assessment:

  1. Vein diameter of > 2.0 mm at target anastomosis site
  2. Clinically significant outflow as determined by outflow mapping (ultrasound or v venography)

• Adequate quality artery base on pre-operative assessment:

  1. Arterial lumen diameter of > 2.0 mm at target anastomosis site
  2. No significant calcification at the anastomosis site
  3. Radial artery at the wrist suitable for catheterization
• Radial artery-adjacent vein proximity < 1.5 mm measured lumen edge-to-lumen edge as determined by pre-procedural ultrasound and confirmed pre-procedure
• Patent palmar arch with adequate collateral perfusion as evidenced by Negative Allen's Test
• Able and willing to follow a daily aspirin and/or other anticoagulation/antiplatelet regimen, not including warfarin (Coumadin, or comparable anti-coagulant)

Exclusion Criteria:

• Documented or suspected central venous stenosis including upper extremity arterial stenosis (≥ 50%)
• History of steal syndrome from a previous hemodialysis vascular access on the ipsilateral side which required intervention or abandonment
• Evidence of clinically significant vascular disease at the radial artery/adjacent vein site on the ipsilateral side
• Systolic pressures < 100 mg Hg at the time of treatment
• Suspected or confirmed skin disease at the skin entry site
• Immunocompromised patients (e.g. HIV positive)
• Edema of the upper extremity on the ipsilateral side
• Patients requiring immunosuppressant therapy such as Sirolimus (Rapamune®) or - Prednisone at a dose of > 10 mg per day
• Peripheral white blood cell count <1.5 K/mm3 or platelet count <75,000 cells/mm3
• Known bleeding diathesis or coagulation disorder
• Receiving warfarin (Coumadin, or comparable anti-coagulant) therapy
• Patients with acute or active infection

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of patients with a vascular access site that achieves a venous diameter of greater than or equal to 4 mm and blood flow greater than or equal to 500 ml/min in the brachial artery as measured via duplex ultrasound.	Primary endpoint	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Ellipsys Vascular Access procedures that successfully create an arteriovenous fistula (AVF) excluding Access Failures.	Device Success Rate	12 months
The length of time until a patient is able to undergo 2-needle cannulation for dialysis OR access vessel has a diameter ≥ 6 mm and a mean flow rate of ≥ 600 ml/min if the patient is not undergoing dialysis.	Time to Functional Patency	12 months
Percent of patients that require dialysis and sustain 3 consecutive 2-needle cannulations at the prescribed needle gauge and blood flow rate.	Dialysis Rate	12 months
The number of surgical or endovascular interventions required to achieve or maintain Functional Patency.	Secondary Procedure Rate	12 months
Number of patients with patency defined as an anastomosis that has flow whether it is being used for dialysis or not.	Arterio-venous fistula patency	12 months
Length of time from initial access creation to achieve Functional Patency or to time of abandonment of AVF.	Cumulative patency	12 months

Collaborators and Investigators

• Sponsor: Medtronic Endovascular

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): April 17, 2019
• Study Completion (Actual): July 30, 2020

Study Registration Dates

• First Submitted: February 27, 2018
• First Submitted That Met QC Criteria: February 27, 2018
• First Posted (Actual): March 5, 2018

Study Record Updates

• Last Update Posted (Actual): February 8, 2021
• Last Update Submitted That Met QC Criteria: February 3, 2021
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: dialysis autogenous arterio-venous fistula
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: 1.0 ver 1.0 23 January 2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes