Ellipsys Vascular Access System for Arteriovenous Fistula

Phase-Based Progress Estimates
STAR Vascular Access Center, San Antonio, TXArteriovenous Fistula+3 MoreEllipsys Vascular Access System - Device
18 - 80
All Sexes
What conditions do you have?

Study Summary

This trial will look at how well the Ellipsys Vascular Access System works in people who need an AV fistula.

Eligible Conditions
  • Arteriovenous Fistula
  • End-Stage Renal Disease
  • End-Stage Kidney Disease
  • Arteriovenous Fistulas

Treatment Effectiveness

Study Objectives

3 Primary · 4 Secondary · Reporting Duration: 12 months post-procedure

12 months post-procedure
Assisted Primary Patency Through 12 months Post-AVF Creation
Cumulative Patency Through 12 months Post-AVF Creation
Overall Patient Safety
Primary Patency Through 12 months Post-AVF Creation
Secondary Procedures Rate
Study Related Serious Adverse Event (SAE) Rate Through 12 months
7 days post-procedure
Early Occlusion Rate at 7 days

Trial Safety

Trial Design

1 Treatment Group

Ellipsys Vascular Access System
1 of 1

Experimental Treatment

134 Total Participants · 1 Treatment Group

Primary Treatment: Ellipsys Vascular Access System · No Placebo Group · N/A

Ellipsys Vascular Access System
Experimental Group · 1 Intervention: Ellipsys Vascular Access System · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months post-procedure

Who is running the clinical trial?

Medtronic EndovascularLead Sponsor
68 Previous Clinical Trials
14,813 Total Patients Enrolled
2 Trials studying Arteriovenous Fistula
433 Patients Enrolled for Arteriovenous Fistula
Haimanot Wasse, MDPrincipal InvestigatorRush University Medical Center

Eligibility Criteria

Age 18 - 80 · All Participants · 14 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a blockage in the flow of fluid in your body that is causing significant health problems.

Frequently Asked Questions

Does the research team consider minors for enrollment in this trial?

"Participants in this medical experiment must be under 80 years old and of legal age." - Anonymous Online Contributor

Unverified Answer

What goals is this endeavor hoping to accomplish?

"This trial intends to measure Early Occlusion Rate at 7 days post-intervention as its principal objective over a timeframe of 12 months. Secondary objectives include Primary Patency Through 12 Months Post-AVF Creation, Assisted Primary Patency Through 12 Months Post-AVF Creation, and the Secondary Procedures Rate which records interventions aimed at maturing or sustaining the AVF's flow per person year." - Anonymous Online Contributor

Unverified Answer

Are there any American locations currently undergoing this clinical experiment?

"Both The Vascular Care Group in Hyannis, Massachusetts and Yale University in New Haven, Connecticut are participating sites for this research endeavour. Rush University Medical Center located in Chicago is also aiding with the study's progression along with 6 other medical centres." - Anonymous Online Contributor

Unverified Answer

How many participants have been accepted into this experiment?

"Indeed, clinicaltrials.gov shows that this research initiative, initially posted on April 13th 2021, is actively enrolling participants. A total of 134 individuals must be recruited from 6 different medical sites." - Anonymous Online Contributor

Unverified Answer

Is this research currently enrolling volunteers?

"According to clinicaltrials.gov, this research is still recruiting participants who meet the criteria stated in the initial post of April 13th 2021 and updated on October 6th 2022." - Anonymous Online Contributor

Unverified Answer

May I be part of this investigation?

"This clinical trial seeks to enrol 134 individuals who are aged between 18 and 80, have been diagnosed with End-Stage Renal Disease (ESRD) or Chronic Kidney Disease on hemodialysis, and can live for at least a year. Applicants must possess an arterial lumen of ≥2.0 mm in the target area along with adequate collateral perfusion as established by Barbeau Test; be medically qualified for upper extremity autogenous AV fistula formation per institutional guidelines/clinical judgement; demonstrate sufficient quality vein & radial artery based on preoperative assessment; display an adjacent vein diameter of ≥2.0 mm at" - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.