Trials / Completed
CompletedNCT01726257
Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix® System
Prospective, Multicenter, Single Arm Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix® System: A Pivotal and Continued Access Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 333 (actual)
- Sponsor
- Endologix · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Nellix System | Subjects in this study will receive a Nellix Endovascular Sealing System as part of their intervention. |
Timeline
- Start date
- 2013-12-01
- Primary completion
- 2016-06-01
- Completion
- 2022-12-01
- First posted
- 2012-11-14
- Last updated
- 2025-02-28
- Results posted
- 2024-11-06
Locations
30 sites across 4 countries: United States, Germany, Netherlands, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT01726257. Inclusion in this directory is not an endorsement.