Ellipsys Vascular Access System Registry

End-stage Renal Disease Clinical Trial

Official title: Ellipsys Vascular Access System Registry, Protocol 1.0. Version 1.0

Status Completed

Clinical Trial 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.

Clinical Trial Description

Ellipsys Vascular Access System Registry is a non-randomized, prospective, post-market, multi-center registry of the Ellipsys Vascular Access System in which up to 100 patients will be enrolled 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 AV fistula via percutaneous access. The primary performance endpoint is Clinical Success at the 90-day endpoint, where Clinical Success is defined as an access site that achieves a venous diameter of greater than or equal to 4 mm and blood flow greater than or equal to 500 ml/min in the brachial artery as measured via duplex ultrasound. ;

Related Conditions & MeSH terms

• End-stage Renal Disease
• Kidney Failure, Chronic

• NCT number: NCT03454113
• Study type: Observational [Patient Registry]
• Source: Medtronic Endovascular
• Status: Completed
• Start date: July 1, 2017
• Completion date: July 30, 2020