NCT03298477

EVAS2 IDE Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study

Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix System IDE Study (EVAS 2 Confirmatory IDE Study)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Endologix · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective, multicenter, single arm study with consecutive, eligible subject enrollment at each site. All subjects will undergo the Endovascular Aneurysm repair procedure with the Nellix System.

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 safety and effectiveness outcomes. 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

• Abdominal Aortic Aneurysm Without Rupture

Interventions

Type	Name	Description
DEVICE	Nellix® System	Endovascular Abdominal Aortic Aneurysm Repair using the Nellix® System

Timeline

• Start date: 2017-12-01
• Primary completion: 2022-06-07
• Completion: 2025-08-16
• First posted: 2017-10-02
• Last updated: 2025-03-19
• Results posted: 2025-03-19

Locations

27 sites across 1 country: United States

Regulatory

• FDA-regulated device study