Ellipsys Fistula for Hemodialysis Access

January 31, 2019 updated by: Richmond Vascular Center

Ellipsys Percutaneous Arteriovenous Fistula for Hemodialysis Access

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

Study Overview

Status

Unknown

Conditions

Detailed Description

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. The Investigator would like to consent previous Ellipsys® patients with appropriate medical records so that the Investigator may capture participants data for outcomes reporting.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood flow Volume
Time Frame: 90 days
Brachial Artery flow volume of 500ml as measured on Ultrasound Duplex
90 days

Collaborators and Investigators

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

Sponsor

Richmond Vascular Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 27, 2018

Primary Completion (Anticipated)

August 27, 2019

Study Completion (Anticipated)

August 27, 2021

Study Registration Dates

First Submitted

October 18, 2018

First Submitted That Met QC Criteria

January 31, 2019

First Posted (Actual)

February 4, 2019

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pAVF 1.0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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