Nellix System for Abdominal Aortic Aneurysm

(EVAS2 Trial)

Not currently recruiting at 31 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to repair abdominal aortic aneurysms, which are bulges in the large blood vessel supplying blood to the abdomen and legs. The focus is on the Nellix® System, a type of endovascular repair. The trial involves one group of participants, all receiving the same treatment to assess its safety and effectiveness. It may suit individuals diagnosed with an abdominal aortic aneurysm that meets specific size criteria and who have not experienced recent heart attacks or other serious conditions. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could lead to new treatment options.

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 prior data suggests that the Nellix System is safe for abdominal aortic aneurysm repair?

Research has shown that the Nellix System, used to repair abdominal aortic aneurysms, has demonstrated good safety results in past studies. One study reported that every procedure was completed successfully, with no immediate problems. Another study found very few complications within the first 30 days post-procedure, a critical period for patient safety. However, some long-term studies have identified more failures over time compared to early results. This indicates that while short-term safety is well-supported, long-term outcomes may vary. Overall, early findings suggest the procedure is generally safe, with most patients experiencing few immediate issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Nellix® System is unique because it offers a new way to treat abdominal aortic aneurysms by using an endovascular aneurysm sealing (EVAS) approach. Unlike the traditional endovascular repair methods, which rely on stents and grafts, the Nellix® System uses polymer-filled endobags to seal the aneurysm sac, potentially reducing the risk of endoleaks, a common complication. Researchers are excited about this treatment because it aims to provide a more effective seal and long-term stability, which could enhance patient outcomes and lower the chances of needing additional interventions.

What evidence suggests that the Nellix System is effective for abdominal aortic aneurysm?

Research has shown that the Nellix System effectively repairs abdominal aortic aneurysms, a bulge in the body's main artery. One study reported a success rate of 98.2% in one group and 97.9% in another, indicating strong initial results. However, failure rates increased over time, similar to other treatments. Despite this, 80% of patients survived after one year, though this decreased to 59.3% after three years. Overall, the Nellix System proves effective in the short term, but its long-term effectiveness can vary. ^{1 2 3 4 6}

Who Is on the Research Team?

Jeffrey Carpenter, MD

Principal Investigator

Cooper Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5967009/

Two-Year Outcomes of the Nellix EndoVascular Aneurysm ... Results: Overall technical success was 98.2% (165/168) in the IFU 2013 group and 97.9% (47/48) in the IFU 2016 subgroup (p=0.428). The 2-year ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1078588423008973

A Single Centre Long Term Follow Up of the Nellix ... Long term follow up of the Nellix stent graft revealed increased failure rates compared with the early studies. The results are comparable to other long term ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01726257

Safety and Effectiveness Study of Endovascular Abdominal ... 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 ...

4. jvascsurg.org jvascsurg.org/article/S0741-5214%2815%2901749-8/fulltext

Results of the Nellix system investigational device ... Systematic review of recent evidence for the safety and efficacy of elective endovascular repair in the management of infrarenal abdominal aortic aneurysm.

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/1457496920917267

Three-Year Results of the Nellix Endovascular Aneurysm ... Survival rates at 1 and 3 years were 80% and 59.3%. Abdominal aortic aneurysm–related mortality occurred in 3 of 15 cases. Freedom from rupture ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7224240/

Outcome of Nellix-EVAS: single center mid-term results Technical success rate of the procedure was 100%. All stent grafts were placed directly below the renal arteries.