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Ellipsys Vascular Access System Registry

NCT03454113 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 17

Last updated 2021-02-08

No results posted yet for this study

Summary

Ellipsys Vascular Access System Registry will enroll up to 100 patients to evaluate the use and performance of the Ellipsys Vascular Access System when it is used within its intended use in accordance with standard of care in a clinical setting. The Ellipsys Vascular Access System is intended for use to create an arteriovenous (AV) fistula via percutaneous access.

Conditions

  • End-stage Renal Disease

Interventions

DEVICE

Ellipsys Vascular Access

The Ellipsys Vascular Access System comprises the Ellipsys Catheter, Ellipsys Crossing Needle and Ellipsys Power Controller. The Ellipsys Crossing Needle is used to facilitate access between the artery and the vein. The Ellipsys Catheter is placed percutaneously into the selected vein in close proximity to the selected artery. The Ellipsys Catheter is actuated at the selected anastomosis site, and the vein and artery are approximated. Once the vessels are in the appropriate relative positions the catheter is connected to the Ellipsys Power Controller to create the anastomosis after which the Ellipsys Catheter is removed, and the access site is closed using standard percutaneous closure techniques.

Sponsors & Collaborators

  • Medtronic Endovascular

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2019-04-17
Completion
2020-07-30
FDA Device
Yes

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03454113 on ClinicalTrials.gov