NCT02996396

Nellix Registry Study: EVAS-Global

Multicenter, Observational, Registry to Assess Outcomes of Patients Treated With the CE Marked Nellix® System for Endovascular Abdominal Aortic Aneurysm Repair"

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (actual)
• Sponsor: Endologix · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Multicenter, single arm, open label, registry study with consecutive, eligible patient enrollment at each site. All subjects undergoing the Endovascular Aneurysm Sealing System (EVAS) with the Nellix®-System. Subjects will be followed procedurally to discharge, and as per institutional standard of care thereafter through to 5 years (total follow-up commitment)

Conditions

• Abdominal Aortic Aneurysm

Interventions

Type	Name	Description
DEVICE	Nellix Endovascular Aneurysm Sealing System (Nellix®-System)	The Nellix system is comprised of two independent flow channels, one to each iliac artery. Each flow channel consists of a balloon-expanded ePTFE covered stent surrounded by a Polymer-filled EndoBag which fills the blood lumen within the aorta, and seals the aneurysm from side-branch flow.

Timeline

• Start date: 2016-11-01
• Primary completion: 2023-11-21
• Completion: 2024-11-01
• First posted: 2016-12-19
• Last updated: 2022-06-07

Locations

10 sites across 4 countries: Germany, Netherlands, New Zealand, Spain