Nellix® Registry Study: EVAS-Global

NCT ID: NCT02018744

Last Updated: 2022-03-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2022-06-30

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Male or female at least 18 years old

2. Subject has signed informed consent for data release

3. Subjects with AAA and eligible for endovascular repair

Exclusion Criteria

1. Currently participating in another study where primary endpoint has not been reached yet

2. Known allergy to any of the device components

3. Pregnant (females of childbearing potential only)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Endologix

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prof Andrew Holden

Role: PRINCIPAL_INVESTIGATOR

Auckland City Hospital

Dr. Michel Reijnen, MD

Role: PRINCIPAL_INVESTIGATOR

Rijnstate Hospital, Arnhem NL

Locations

Klinikum Augsburg Klinik für Gefäßchirurgie

Augsburg, , Germany

Universitätsklinikum Düsseldorf Klinik für Gefäß- und Endovaskularchirurgie

Düsseldorf, , Germany

Alfried Krupp Krankenhaus Ruttenscheid, Vascular Centre

Essen, , Germany

Universitätsklinikum Heidelberg Klinik für Gefäßchirurgie Im Neuenheimer Feld

Heidelberg, , Germany

Klinikum Sud Nuernberg, Dept of Vascular Surgery

Nuremberg, , Germany

Klinikum Stuttgart Katharinenen Hospital

Stuttgart, , Germany

Pauls Stadins Clinical University Hospital Riga

Riga, , Latvia

Hopital Kirchberg, Dept of Cardio-Vascular

Luxembourg-Kirchberg, , Luxembourg

Academisch Medisch Centrum Amsterdam, Department of Surgery

Amsterdam, , Netherlands

Rijnstate Ziekenhuis, Vasculaire Centrum

Arnhem, , Netherlands

St Antonius Ziekenhuis, Dept of Vascular Surgery

Nieuwegein, , Netherlands

Erasmus Medical Centre, Dept of Vascular Surgery

Rotterdam, , Netherlands

St Elisabeth Ziekenhuis, Dept of Vascular Surgery

Tilburg, , Netherlands

Auckland City Hospital Interventional Radiology

Auckland, , New Zealand

Hospital Hamar

Hamar, , Norway

Orebro University Hospital, Department of General Surgery

Örebro, , Sweden

Karolinska University Hospital

Stockholm, , Sweden

Addenbrooke's Hospital, Dept of Vascular Surgery

Cambridge, , United Kingdom

St. George's Vascular Institute

London, , United Kingdom

Countries

Germany; Latvia; Luxembourg; Netherlands; New Zealand; Norway; Sweden; United Kingdom

Other Identifiers

CP0010-Ver. 1

Identifier Type: -

Identifier Source: org_study_id