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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.
Official title: Multicenter, Observational, Post-Market, Real World Registry to Assess Outcomes of Patients Treated With the Nellix® System for Endovascular Abdominal Aortic Aneurysm Repair
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
300
Start Date
2013-10
Completion Date
2022-07-07
Last Updated
2026-05-08
Healthy Volunteers
No
Locations (19)
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