This trial is active, not recruiting.

Condition safety and performance of the nellix endovascular sealing system
Sponsor Endologix
Start date October 2013
End date September 2014
Trial size 300 participants
Trial identifier NCT02018744, EVAS-Global


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Immediate procedural technical success
time frame: Procedure
Peri-operative Safety Parameters
time frame: Up to 30 days
Clinical outcome
time frame: Up to 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

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
Principal investigator Prof Matt Thompson
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
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by Endologix.