Ellipsys Fistula for Hemodialysis Access

ESRD Clinical Trial

Official title:

Ellipsys Percutaneous Arteriovenous Fistula for Hemodialysis Access

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03828253
• Other study ID #: pAVF 1.0
• Status: Recruiting
• Start date: August 27, 2018
• Est. completion date: August 27, 2021

Study information

• Verified date: January 2019
• Source: Richmond Vascular Center
• Contact: Tricia Eichenlaub, RN
• Phone: 804-864-8346
• Email: Teichenlaub[@]Richmondvascularcenter.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 27, 2021
• Est. primary completion date: August 27, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ESRD
• Fistula

Locations

Country	Name	City	State
United States	Richmond Vascular Center	North Chesterfield	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Richmond Vascular Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood flow Volume	Brachial Artery flow volume of 500ml as measured on Ultrasound Duplex	90 days