Ellipsys Fistula for Hemodialysis Access

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-27

Study Completion Date

2021-08-27

Brief Summary

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

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Detailed Description

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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.

Conditions

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ESRD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No