Nellix System for Abdominal Aortic Aneurysm

(EVAS2 Trial)

Recruiting at 30 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Endologix

Disqualifiers: Coagulopathy, Connective tissue diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 31

Duration: 1 day

98 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the Nellix System treatment for abdominal aortic aneurysm?

The Nellix System showed encouraging results in a trial with low complications and high success rates in treating abdominal aortic aneurysms, although some issues with device migration were noted, leading to refinements in its use. Additionally, in a study of patients with both abdominal aortic aneurysm and iliac artery disease, the treatment was technically successful and effective in maintaining open arteries and stable aneurysm sizes. ^{1 2 3 4 5}

Is the Nellix System for Abdominal Aortic Aneurysm generally safe for humans?

The available research does not provide specific safety data for the Nellix System for Abdominal Aortic Aneurysm, but it discusses adverse events in similar medical procedures and systems, highlighting the importance of tracking and managing minor adverse events to ensure patient safety. ^{6 7 8 9 10}

How is the Nellix System treatment different from other treatments for abdominal aortic aneurysm?

The Nellix System is unique because it uses a polymer to fill and manage the aneurysm sac, unlike traditional methods that rely on stents or open surgery. This approach, known as endovascular aneurysm sealing (EVAS), aims to provide a more effective and less invasive treatment option for abdominal aortic aneurysms. ^{1 2 3 4 11}

Research Team

Jeffrey Carpenter, MD

Principal Investigator

Cooper Hospital

Eligibility Criteria

This trial is for adults with abdominal aortic aneurysms that are large or growing quickly, who have suitable blood vessel anatomy for the Nellix System. Participants must understand and sign consent forms, agree to follow-up visits, and not be pregnant or have certain health conditions like severe kidney issues or recent heart attacks.

Inclusion Criteria

My abdominal aortic aneurysm is larger than 5.0cm, or it has grown by more than 0.5cm in the last 6 months.

Informed consent form understood and signed

Patient agrees to all follow-up visits

Exclusion Criteria

I have a significant blood clot in the area where my abdominal aorta meets my kidneys.

Psychiatric or other condition that may interfere with the study

Participating in another clinical study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-procedure Imaging

Participants undergo a high resolution, contrast-enhanced computed tomography angiography (CT) scan of the relevant aortic and aortoiliac vasculature

Up to 3 months before procedure

Treatment

Endovascular Aneurysm repair procedure with the Nellix System

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits to assess aneurysm morphology, the status of the implanted devices, and relevant laboratory test results

5 years

Visits at 30 days, 6 months, and annually to 5 years

Treatment Details

Interventions

• Nellix® System

Trial Overview The study is testing the safety and effectiveness of the Nellix System in repairing abdominal aortic aneurysms. It's a single group study where all participants will receive this endovascular repair procedure at various medical centers.

Participant Groups

Group I: Single Arm Experimental Treatment 1 Intervention

Single Arm Safety and Effectiveness Confirmatory Study of EVAS using the Nellix® System

Who Is Running the Clinical Trial?

Endologix

Lead Sponsor

Trials

23

Recruited

3,900+

Findings from Research

The Nellix endovascular aneurysm sealing system is a new type of aortic stent designed to improve upon traditional endovascular aneurysm repair methods.

In a case study of a 65-year-old male, a misdiagnosis of acute aortic dissection occurred 7 days after Nellix stent insertion, emphasizing the need for awareness of the stent's unique radiological appearances to avoid diagnostic errors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Misdiagnosis of abdominal aortic dissection: image findings with the Nellix endovascular aneurysm sealing system. de Souza, PJ., Rodway, A., Pankhania, A.[2020]

The web-based adverse event tracking system (eAETS) has effectively supported 175 clinical protocols over four years, capturing 2,440 adverse event reports, including minor symptoms that could indicate serious issues.

Out of the reported AEs, 1,053 did not align with the initial risk profiles, leading to corrective recommendations in 13% of the protocols, highlighting the system's role in enhancing subject safety by identifying unanticipated patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of minor adverse event tracking on subject safety: a web-based system. Shenvi, NV., Gebhart, SS.[2009]

A continuous surveillance system for adverse events (AEs) in surgical services was successfully designed and implemented, capturing data on 70% of patients and identifying an incidence of 11.2 AEs per 100 admissions, with 47% classified as surgical complications.

The system's effectiveness relies on ease of data input and rapid feedback, highlighting the importance of professional participation in improving surgical safety and identifying areas for enhancement in hospital practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[An adverse event continuous surveillance system in surgical services of the autonomous region of Cantabria (Spain)]. Rebollo-Rodrigo, H., Madrazo-Leal, C., Gómez-Fleitas, M.[2010]

In a survey of 17 European countries, it was found that while 13 have regulations for reporting adverse vaccine reactions, only six have full-time professionals dedicated to vaccine safety, highlighting a significant gap in resources and expertise.

The study revealed that reporting systems for adverse events following immunization (AEFI) are inconsistent across countries, with many lacking standardized definitions and reporting forms specifically designed for vaccines, which complicates the assessment of vaccine safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaccinovigilance in Europe--need for timeliness, standardization and resources. Lankinen, KS., Pastila, S., Kilpi, T., et al.[2015]

The review highlights an increasing trend in adverse events associated with clinical catheters, emphasizing the need for better understanding and management of these risks.

By analyzing numerous clinical studies and literature, the review aims to identify common adverse events and their causes, providing evidence to help reduce the incidence of these events and prevent serious complications during catheter use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Analysis of Adverse Events in Clinical Use of Catheter]. Yin, J., Wang, Y., Zhang, L., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Refinement of anatomic indications for the Nellix System for endovascular aneurysm sealing based on 2-year outcomes from the EVAS FORWARD IDE trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

The morphological applicability of a novel endovascular aneurysm sealing (EVAS) system (Nellix) in patients with abdominal aortic aneurysms. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Misdiagnosis of abdominal aortic dissection: image findings with the Nellix endovascular aneurysm sealing system. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Open conversion after Nellix endovascular aneurysm sealing. [2020]

5. England pubmed.ncbi.nlm.nih.gov

The Nellix™ EndoVascular sealing system in patients with abdominal aortic aneurysms in conjunction with iliac artery occlusive disease. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse events after endoluminal repair of abdominal aortic aneurysms: a comparison during two successive periods of time. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

The impact of minor adverse event tracking on subject safety: a web-based system. [2009]

8. Spain pubmed.ncbi.nlm.nih.gov

[An adverse event continuous surveillance system in surgical services of the autonomous region of Cantabria (Spain)]. [2010]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Vaccinovigilance in Europe--need for timeliness, standardization and resources. [2015]

10. China pubmed.ncbi.nlm.nih.gov

[Analysis of Adverse Events in Clinical Use of Catheter]. [2018]

11. New Zealand pubmed.ncbi.nlm.nih.gov

The Nellix endovascular aneurysm sealing system: current perspectives. [2022]