Nellix® Registry Study: EVAS-Global

• Conditions: Safety and Performance of the Nellix Endovascular Sealing System

• Registration Number: NCT02018744
• Lead Sponsor: Endologix

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

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-11-18
• Study First Submitted QC: 2013-12-17
• Study First Posted: 2013-12-23
• Primary Completion: 2019-09
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-02
• Last Update Posted: 2022-03-03
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immediate procedural technical success	Procedure	Number of subjects where immediate procedural technical success during procedure was noted
Peri-operative Safety Parameters	Up to 30 days	Number of subjects with procedural Blood loss \>1000mL, Mortality (all-cause), Bowel Ischemia, Paraplegia, Renal Failure, Myocardial Infarction, Respiratory Failure, Stroke
Clinical outcome	Up to 5 years	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)

Trial Locations

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; 🇩🇪 Nuernberg, 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

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