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Ellipsys Fistula for Hemodialysis Access

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03828253
Recruitment Status : Unknown
Verified January 2019 by Richmond Vascular Center.
Recruitment status was:  Recruiting
First Posted : February 4, 2019
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Richmond Vascular Center

Study Description
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Brief Summary:
To report the outcomes of patients having percutaneous proximal radial artery fistula creation.

Condition or disease
ESRD

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Ellipsys Percutaneous Arteriovenous Fistula for Hemodialysis Access
Actual Study Start Date : August 27, 2018
Estimated Primary Completion Date : August 27, 2019
Estimated Study Completion Date : August 27, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Blood flow Volume [ Time Frame: 90 days ]
    Brachial Artery flow volume of 500ml as measured on Ultrasound Duplex


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.

Criteria

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
Contacts and Locations
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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): NCT03828253


Contacts
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Contact: Tricia Eichenlaub, RN 804-864-8346 Teichenlaub@Richmondvascularcenter.com
Contact: Brittani Lewis 804-864-8346 Blewis@Richmondvascularcenter.com

Locations
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United States, Virginia
Richmond Vascular Center Recruiting
North Chesterfield, Virginia, United States, 23236
Contact: Tricia Eichenlaub, RN    804-864-8346    Teichenlaub@richmondvascularcenter.com   
Contact: Brittani Lewis    804-864-8346    Blewis@Richmondvascularcenter.com   
Principal Investigator: Jeffrey Hull, MD         
Sponsors and Collaborators
Richmond Vascular Center
Investigators
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Principal Investigator: Jeffrey Hull, MD Richmond Vascular Center
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Richmond Vascular Center
ClinicalTrials.gov Identifier: NCT03828253    
Other Study ID Numbers: pAVF 1.0
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fistula
Pathological Conditions, Anatomical