Last updated on February 2018

Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix System


Brief description of study

The objective of this study is to assess the safety and effectiveness of the Endologix Nellix System for the endovascular repair of infrarenal abdominal aortic aneurysms (AAA).

Detailed Study Description

This study will evaluate the safety and effectiveness of the Nellix System among a wide range of physicians and in consecutively enrolled subjects to assess outcomes generalizability. Following appropriate government and ethics committee/IRB approval the Nellix EndoVascular Sealing System will be implanted into eligible patients who are adequately informed and have consented to join the study. Enrolled patients will undergo a high resolution, contrast-enhanced computed tomography angiography (CT) scan of the relevant aortic and aortoiliac vasculature within three months of the scheduled procedure and at specified follow-up intervals post-implantation. Follow-up visits will occur at 30 days, 6 months, and annually to 5 years to assess aneurysm morphology, the status of the implanted devices, and relevant laboratory test results.

Clinical Study Identifier: NCT01726257

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St. Vincent Heart Center of Indiana

Indianapolis, IN United States
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