Ellipsys Fistula for Hemodialysis Access

Richmond Vascular Center

Status: Unknown

Conditions: ESRD

Study type: Observational

Funder types: Other

Identifiers

NCT03828253

pAVF 1.0

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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