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Clinical Trials/NCT03828253
NCT03828253UnknownNot Applicable

Ellipsys Percutaneous Arteriovenous Fistula for Hemodialysis Access

Richmond Vascular Center1 site in 1 country100 target enrollmentStarted: August 27, 2018Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
Blood flow Volume
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

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

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Blood flow Volume

Time Frame: 90 days

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Richmond Vascular Center
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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