North Chesterfield, Virginia 23236


Purpose:

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


Study summary:

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.


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


NCT ID:

NCT03828253


Primary Contact:

Principal Investigator
Jeffrey Hull, MD
Richmond Vascular Center

Tricia Eichenlaub, RN
Phone: 804-864-8346
Email: Teichenlaub@Richmondvascularcenter.com


Backup Contact:

Email: Blewis@Richmondvascularcenter.com
Brittani Lewis
Phone: 804-864-8346


Location Contact:

North Chesterfield, Virginia 23236
United States

Tricia Eichenlaub, RN
Phone: 804-864-8346
Email: Teichenlaub@richmondvascularcenter.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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