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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nellix System | Nellix 3SQ+ device |
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| Measure | Description | Time Frame |
|---|---|---|
| Immediate procedural technical success | Number of subjects where immediate procedural technical success during procedure was noted | Procedure |
| Peri-operative Safety Parameters | Number of subjects with procedural Blood loss >1000mL, Mortality (all-cause), Bowel Ischemia, Paraplegia, Renal Failure, Myocardial Infarction, Respiratory Failure, Stroke | Up to 30 days |
| Clinical outcome | Number of subjects with Aneurysm rupture, Conversion to open surgical repair, Endoleak of any type, Clinically significant migration, Aneurysm enlargement through to five years, Secondary endovascular procedures of any type through to five years, Secondary endovascular procedures for (resolution of Endoleak of any type; Device occlusion (due to thrombus or other causes); Device migration AAA sac expansion (>5mm diameter increase); Device defect) | Up to 5 years |
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| Measure | Description | Time Frame |
|---|---|---|
| Device Patency and Integrity | Number of subjects with device patency and integrity throughout the study. | Up to 5 years |
| In-hospital evaluations | Evaluation of total amount of polymer fill, total endovascular time, anaesthesia time, fluoroscopy time, contrast volume used, total procedure time, estimated blood loss, incidence of transfusion, time in ICU, time to hospital discharge |
Inclusion Criteria:
Exclusion Criteria:
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Up to 300 patients diagnosed with AAA who are considered candidates for Endovascular Repair, who meet the study eligibility criteria and sign the Informed consent may be subsequently enrolled in the study
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| Name | Affiliation | Role |
|---|---|---|
| Prof Andrew Holden, MBChB | Auckland City Hospital | Principal Investigator |
| Dr. Michel Reijnen, MD | Rijnstate Hospital, Arnhem NL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Augsburg Klinik für Gefäßchirurgie | Augsburg | 86156 | Germany | |||
| Universitätsklinikum Düsseldorf Klinik für Gefäß- und Endovaskularchirurgie |
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| Discharge |
| Distal Complications | Incidence of distal thrombosis, embolization and iliac stenosis. | 5 years |
| Düsseldorf |
| 40225 |
| Germany |
| Alfried Krupp Krankenhaus Ruttenscheid, Vascular Centre | Essen | 45131 | Germany |
| Universitätsklinikum Heidelberg Klinik für Gefäßchirurgie Im Neuenheimer Feld | Heidelberg | 69120 | Germany |
| Klinikum Sud Nuernberg, Dept of Vascular Surgery | Nuremberg | 90471 | Germany |
| Klinikum Stuttgart Katharinenen Hospital | Stuttgart | 70174 | Germany |
| Pauls Stadins Clinical University Hospital Riga | Riga | LV-1002 | Latvia |
| Hopital Kirchberg, Dept of Cardio-Vascular | Luxembourg-Kirchberg | L-2540 | Luxembourg |
| Academisch Medisch Centrum Amsterdam, Department of Surgery | Amsterdam | 1105AZ | Netherlands |
| Rijnstate Ziekenhuis, Vasculaire Centrum | Arnhem | 6800 TA | Netherlands |
| St Antonius Ziekenhuis, Dept of Vascular Surgery | Nieuwegein | 3435 CM | Netherlands |
| Erasmus Medical Centre, Dept of Vascular Surgery | Rotterdam | 3015 CE | Netherlands |
| St Elisabeth Ziekenhuis, Dept of Vascular Surgery | Tilburg | 5022 GC | Netherlands |
| Auckland City Hospital Interventional Radiology | Auckland | 1023 | New Zealand |
| Hospital Hamar | Hamar | 2326 | Norway |
| Orebro University Hospital, Department of General Surgery | Örebro | Sweden |
| Karolinska University Hospital | Stockholm | SE-171 | Sweden |
| Addenbrooke's Hospital, Dept of Vascular Surgery | Cambridge | CB20QQ | United Kingdom |
| St. George's Vascular Institute | London | SW170QT | United Kingdom |