NCT03454113

Ellipsys Vascular Access System Registry

Ellipsys Vascular Access System Registry, Protocol 1.0. Version 1.0

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 17 (actual)
• Sponsor: Medtronic Endovascular · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• End-stage Renal Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-07-01
• Primary completion: 2019-04-17
• Completion: 2020-07-30
• First posted: 2018-03-05
• Last updated: 2021-02-08

Locations

5 sites across 1 country: Germany

Regulatory

• FDA-regulated device study