NCT02018744

Nellix® Registry Study: EVAS-Global

Multicenter, Observational, Post-Market, Real World Registry to Assess Outcomes of Patients Treated With the 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

This registry has been designed as a multicenter, single arm, open label, post-market 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 up to discharge discharge, and as per institutional standard of care thereafter through to 5 years (total follow-up commitment). This registry of the Nellix System, which has received the market authorization of the European Union (Conformité Européenne, CE-certification) in a "real world" patient population treated in a multicenter setting will provide an assessment of the generalizability of the approach and System. Up to 300 patients diagnosed with abdominal aortic aneurysm (AAA) who are considered candidates for Endovascular Repair, in up to 30 international centers will be enrolled in the study.

Detailed description

1. Baseline: medical history, physical exams, CT image, bloodwork, 2. Procedure: implantation information 3. Discharge: Physical exam, bloodwork and adverse events, if any 4. Follow-up according to institutional standard through to 5 years including Physical exam, CT image or standard of care imaging eg Doppler Ultrasound, bloodwork and adverse events, if any

Conditions

• Safety and Performance of the Nellix Endovascular Sealing System

Timeline

• Start date: 2013-10-01
• Primary completion: 2019-09-01
• Completion: 2022-06-30
• First posted: 2013-12-23
• Last updated: 2022-03-03

Locations

19 sites across 8 countries: Germany, Latvia, Luxembourg, Netherlands, New Zealand, Norway, Sweden, United Kingdom