Status:
UNKNOWN
Ellipsys Fistula for Hemodialysis Access
Lead Sponsor:
Richmond Vascular Center
Conditions:
ESRD
Eligibility:
All Genders
18+ years
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 exclud...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 27 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 27 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03828253
Start Date
August 27 2018
End Date
August 27 2021
Last Update
February 4 2019
Active Locations (1)
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1
Richmond Vascular Center
North Chesterfield, Virginia, United States, 23236