Percutaneous Less Invasive AV Fistula for Vascular Access in ESRD
NCT02363972 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 103
Last updated 2021-11-09
Summary
A prospective single-arm well-controlled study to evaluate the safety and effectiveness of a less invasive means of establishing vascular access to facilitate dialysis in patients with end stage renal disease.
Conditions
- End Stage Renal Disease
- AV Fistula
- Fistula
- End Stage Kidney Disease
Interventions
- DEVICE
-
Ellipsys Vascular Access Catheter
A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae.
Sponsors & Collaborators
-
Medtronic Endovascular
lead INDUSTRY
Principal Investigators
-
Jeffrey Hull, MD · Richmond Vascular Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-02-10
- Primary Completion
- 2016-06-30
- Completion
- 2016-06-30
Countries
- United States
Study Locations
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