CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 142 enrolled / 142 target
Drug / intervention
Ellipsys Vascular Access Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04484220
NCT04484220N/ACompletedMonitor (2.3/mo)Completion was 15mo ago
CompareCT.gov

Ellipsys Vascular Access System Post Market Surveillance (PS) Study PS200001 Reference DEN170004

Medtronic Endovascular·interventional·Posted Jul 23, 2020·Updated Jun 1, 2026

In Brief

A clinical study evaluating Ellipsys Vascular Access System for Renal Disease, End Stage and 3 related conditions. Completed, enrolled 142 participants across 12 sites.

Signals

Enrolling slower than its timeline implies

Detailed Summary

The proposed clinical study is a prospective, non-randomized, multi-center, single-arm, observational, post-market surveillance (PS) study of the Ellipsys Vascular Access System in subjects eligible for arteriovenous (AV) fistula.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Disease, End Stage, Kidney Disease, End-Stage, AV Fistula, Fistulas Arteriovenous
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJul 23, 2020
Enrollment StartApr 13, 2021
Primary CompletionMar 31, 2025
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 5.9 years ago

Arms & Interventions

Ellipsys Vascular Access Systemexperimental

The Ellipsys System is indicated for the creation of a proximal radial artery to perforating vein anastomosis via a retrograde venous access approach in patients who have chronic kidney disease requiring dialysis.

Device: Ellipsys Vascular Access System

Interventions

Ellipsys Vascular Access Systemdevice

The Ellipsys System is indicated for the creation of a proximal radial artery to perforating vein anastomosis via a retrograde venous access approach in patients with a minimum vessel diameter of 2.0mm and less than 1.5mm of separation between the artery and vein at the fistula creation site who have chronic kidney disease requiring dialysis.