LIFE Device for Aortic Aneurysm

(LIFE Trial)

Overseen By Jennifer Randolph, Nurse, Clinical Research, RN, BSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jonathan Bath

Must not be taking: Anticoagulants

Disqualifiers: Allergies, Coagulopathy, Obesity, others

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

Compensation: Varies

Number of Visits: 31

Duration: Procedure

15 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn about a new device, named the LIFE device, to treat people with aneurysms (swellings) in the aorta (large, main blood vessel that delivers blood from the heart to the body). The main questions this trial aims to answer are: * If the LIFE device works to treat aortic aneurysms * What medical problems participants have when the LIFE device is used Participants will undergo treatment with the LIFE device and thereafter at 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years have their pulses checked, bloodwork to check kidney function (BUN and serum creatinine), and a CT scan of the aneurysm area.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on anticoagulation (blood-thinning) medication, you may need to discuss this with the trial team, as there are specific criteria related to anticoagulation use.

What data supports the effectiveness of the LIFE Device System treatment for aortic aneurysm?

Research shows that endovascular repair, which includes using devices like the LIFE Device System, has significantly reduced complications compared to traditional open surgery for aortic aneurysms. These devices offer a minimally invasive option that improves survival rates and reduces recovery time, making them beneficial for patients who are at high risk for open surgery. ^{1 2 3 4 5}

Is the LIFE Device for Aortic Aneurysm safe for humans?

Research on endovascular devices, like the LIFE Device, for treating aortic aneurysms shows that they generally reduce complications compared to traditional surgery. However, there can still be device-related complications during the procedure, and long-term follow-up is important to monitor safety. ^{2 6 7 8 9}

How does the LIFE Device System treatment for aortic aneurysm differ from other treatments?

The LIFE Device System for aortic aneurysm is unique because it likely involves a modular endovascular stent-graft, which allows for customization during implantation to fit the patient's anatomy. This flexibility can lead to better outcomes compared to traditional surgical methods or earlier stent-graft designs, which were less adaptable. ^{5 10 11 12 13}

Research Team

Jonathan Bath, MD

Principal Investigator

University of Missouri School - Columbia

Eligibility Criteria

This trial is for adults with large aortic aneurysms who are at high risk for rupture and not suitable for open repair due to various health risks or conditions. Candidates should have specific measurements in their blood vessels to fit the LIFE device, and they must be able to travel to the trial sites.

Inclusion Criteria

The graft in my body is placed at least 5 mm away from a major blood vessel branch.

I cannot travel to sites for special device treatments.

I have a large aortic aneurysm or one that's growing quickly.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo endovascular aneurysm repair using the LIFE Device System

Procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with regular check-ups including pulse checks, bloodwork, and CT scans

5 years

Visits at 30 days, 6 months, 1, 2, 3, 4, and 5 years

Treatment Details

Interventions

• LIFE Device System

Trial Overview The study tests the LIFE device system's effectiveness in treating aortic aneurysms. Participants will receive this new treatment and undergo follow-up evaluations including pulse checks, kidney function tests, and CT scans over five years.

Participant Groups

Group I: Endovascular Aneurysm Repair Experimental Treatment 1 Intervention

Fenestrated Endovascular Aneurysm Repair using the LIFE Device System

Who Is Running the Clinical Trial?

Jonathan Bath

Lead Sponsor

Trials

1

Recruited

20+

University of Missouri-Columbia

Collaborator

Trials

387

Recruited

629,000+

Findings from Research

In a study involving 10 patients with abdominal aortic aneurysms, 8 successfully received an endovascular graft through a transfemoral approach, demonstrating the procedure's safety and effectiveness.

Follow-up results showed that 6 out of 8 patients had normal function with complete aneurysm thrombosis, while 2 had incomplete thrombosis but no further expansion, indicating promising outcomes for this new device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repair of abdominal aortic aneurysm by transfemoral endovascular graft placement. Moore, WS., Vescera, CL.[2019]

The Anaconda modular stent-graft system was successfully used for endovascular repair of an infrarenal abdominal aortic aneurysm, demonstrating both safety and effectiveness.

Patients experienced good clinical outcomes in both the immediate and early longer-term postoperative periods, indicating the reliability of this treatment method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[First experience with the Anaconda modular endovascular stent graft used for treatment of infrarenal aortic aneurysms]. Khabazov, RI., Troitskiĭ, AV., Beliakov, GA.[2016]

Endoluminal grafting procedures for excluding abdominal aortic aneurysms show promise, particularly with advancements in 2nd- and 3rd-generation technologies that have reduced complications like endoleaks and thrombosis.

Despite the potential benefits, the development and clinical testing of these devices are lengthy processes influenced by regulatory environments, indicating that further research is needed to ensure their long-term effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current status of endoluminal grafting for exclusion of abdominal aortic aneurysms. The beauty and the beast. Diethrich, EB.[2018]

References

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

Multicenter pivotal trial results of the Lifepath System for endovascular aortic aneurysm repair. [2012]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Endovascular treatment of aortic aneurysms: techniques and clinical update. [2008]

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

Abdominal aortic aneurysm-repair devices. [2014]

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

Endograft technology: highlights of the past 10 years. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Expert consensus document on the treatment of descending thoracic aortic disease using endovascular stent-grafts. [2022]

6. England pubmed.ncbi.nlm.nih.gov

The evolving technique of endovascular stenting of abdominal aortic aneurysm; time for reappraisal. [2004]

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

Repair of abdominal aortic aneurysm by transfemoral endovascular graft placement. [2019]

8. 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]

9. Ireland pubmed.ncbi.nlm.nih.gov

Complete ten-year follow-up after endovascular abdominal aortic aneurysm repair: survival and causes of death. [2022]

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

Varying strategies for endovascular repair of abdominal an iliac artery aneurysms. [2019]

11. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[First experience with the Anaconda modular endovascular stent graft used for treatment of infrarenal aortic aneurysms]. [2016]

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

Modular systems in the treatment of abdominal aortic aneurysms: lessons learned in the development of designer endografts. [2004]

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

Current status of endoluminal grafting for exclusion of abdominal aortic aneurysms. The beauty and the beast. [2018]