Ellipsys Fistula for Hemodialysis Access

NCT03828253 | Unknown

• 1 other identifier: pAVF 1.0
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

To report the outcomes of patients having percutaneous proximal radial artery fistula creation.

Conditions

ESRD

Outcome Measures

Primary Outcomes (1)

• Blood flow Volume

  Brachial Artery flow volume of 500ml as measured on Ultrasound Duplex

  90 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Recruitment of subjects will be from the current End Stage Renal disease patient population at Richmond Vascular Center and referrals from Nephrologists and Vascular Surgeons. The study would like to enroll up to 100 patients without age, gender-based, race and ethnicity enrollment restrictions for adults over 18 years of age. Women of child bearing potential are not excluded. If a pregnant patient required, an arteriovenous fistula for hemodialysis an Ellipsys® fistula would be an option. We would like to consent previous Ellipsys® patients with appropriate medical records so that we may capture their data for outcomes reporting.

You may qualify if:

• Patient age \> 18 years or older
• Diagnosed with ESRD or chronic kidney disease requiring dialysis or anticipating start of dialysis
• Adjacent vein diameter of \> 2.0 mm at target anastomosis site and confirmed clinically significant outflow
• Arterial lumen diameter of \> 2.0 mm at target anastomosis site
• Adequate collateral arterial perfusion: Barbeau test grade A through C
• Radial artery -adjacent vein proximity \< 1.5 mm measured lumen edge-to-lumen edge via ultrasound

You may not qualify if:

• Target vessel that are \< 2mm is diameter
• Distance between the target artery and vein \> 1.5 mm
• Edema of the upper extremity on the ipsilateral side
• Barbeau test grade D

Sponsors & Collaborators

• Richmond Vascular Center: lead

Study Sites (1)

Richmond Vascular Center

North Chesterfield, Virginia, 23236, United States

RECRUITING

Related Publications (1)

• Hull J, Deitrick J, Groome K. Maturation for Hemodialysis in the Ellipsys Post-Market Registry. J Vasc Interv Radiol. 2020 Sep;31(9):1373-1381. doi: 10.1016/j.jvir.2020.03.001. Epub 2020 Aug 14.

  PMID: 32800660 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeffrey Hull, MD

  Richmond Vascular Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tricia Eichenlaub, RN

CONTACT

804-864-8346; Teichenlaub@Richmondvascularcenter.com

Brittani Lewis

CONTACT

804-864-8346; Blewis@Richmondvascularcenter.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: February 4, 2019
• Study Start: August 27, 2018
• Primary Completion: August 27, 2019
• Study Completion: August 27, 2021
• Last Updated: February 4, 2019

Record last verified: 2019-01

Locations

US (1)