Nellix Registry Study: EVAS-Global (EVAS FORWARD 2)

Endologix

Status: Active, not recruiting

Conditions: Abdominal Aortic Aneurysm

Treatments: Device: Nellix Endovascular Aneurysm Sealing System (Nellix®-System)

Study type: Observational

Funder types: Industry

Identifiers

NCT02996396

CP0010 Ver. 2

Details and patient eligibility

About

Multicenter, single arm, open label, 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 procedurally to discharge, and as per institutional standard of care thereafter through to 5 years (total follow-up commitment)

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female at least 18 years old
2. Subject has signed informed consent for data release
3. Subjects with 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)

Trial design

300 participants in 1 patient group

1

Description:

Patients diagnosed with AAA who are considered candidates for Endovascular Repair and meet the study eligibility criteria and sign the Informed consent may be subsequently enrolled in the study.

Treatment:

Device: Nellix Endovascular Aneurysm Sealing System (Nellix®-System)