Nellix Registry Study: EVAS-Global

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2024-11-30

Brief Summary

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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)

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Detailed Description

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Conditions

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Abdominal Aortic Aneurysm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

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.

Nellix Endovascular Aneurysm Sealing System (Nellix®-System)

Intervention Type DEVICE

The Nellix system is comprised of two independent flow channels, one to each iliac artery. Each flow channel consists of a balloon-expanded ePTFE covered stent surrounded by a Polymer-filled EndoBag which fills the blood lumen within the aorta, and seals the aneurysm from side-branch flow.

Interventions

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Nellix Endovascular Aneurysm Sealing System (Nellix®-System)

The Nellix system is comprised of two independent flow channels, one to each iliac artery. Each flow channel consists of a balloon-expanded ePTFE covered stent surrounded by a Polymer-filled EndoBag which fills the blood lumen within the aorta, and seals the aneurysm from side-branch flow.

Intervention Type DEVICE

Other Intervention Names

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Nellix EVAS FORWARD 2

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No