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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new device called the LIFE device, designed to treat aortic aneurysms. Aortic aneurysms are serious swellings in the large blood vessel that carries blood from the heart to the rest of the body. The study aims to determine if the LIFE device can effectively treat these aneurysms and identify any potential side effects. It is suitable for individuals with a large or rapidly growing aortic aneurysm who cannot undergo open surgery and often rely on other medical treatments, such as oxygen or blood thinners. Participants must commit to regular follow-ups over several years to monitor their health. As an unphased trial, this study offers patients the chance to contribute to groundbreaking research that could lead to new treatment options.

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 prior data suggests that the LIFE device is safe for treating aortic aneurysms?

Research shows that endovascular devices, such as the LIFE device, are generally safe for treating aortic aneurysms. Endovascular repair involves using a tube-like device, called a graft, to support the weakened part of the aorta. Studies indicate that these devices effectively prevent aneurysm complications and are well-tolerated by patients.

However, similar devices have raised concerns in the past. Some required extra monitoring due to safety issues. These devices are constantly improving, and doctors closely monitor them for any problems.

In summary, the LIFE device aims to provide a safe and effective treatment for aortic aneurysms. While past experiences with similar devices suggest good safety, ongoing research and monitoring help ensure the best outcomes for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The LIFE Device System is unique because it offers a new way to repair aortic aneurysms using a technique called fenestrated endovascular aneurysm repair (FEVAR). Unlike traditional open surgery, which involves a large incision to access the aorta, this system is minimally invasive, using a catheter to place a custom-fitted stent inside the blood vessel. Researchers are excited about this treatment because it can be tailored to fit the unique anatomy of each patient's aorta, potentially reducing recovery time and minimizing complications compared to conventional methods.

What evidence suggests that the LIFE device is effective for treating aortic aneurysms?

Research has shown that the LIFE device for treating aortic aneurysms is promising. In this trial, participants will undergo a less invasive surgery called endovascular aneurysm repair using the LIFE Device System. Studies on this procedure found no cases of aneurysm ruptures and no need to switch to open surgery. After six months, all patients survived, and after one year, 93.3% remained alive. The success rate of these repairs was about 96%. These results suggest that the LIFE device could be a safe and effective treatment for aortic aneurysms, with a high chance of success and survival. ^{6 7 8 9 10}

Who Is on the Research Team?

Jonathan Bath, MD

Principal Investigator

University of Missouri School - Columbia

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1856532/

Long-term Outcomes After Endovascular Abdominal Aortic ... Cumulative survival was 52% at 5 years. Conclusions: EVAR using contemporary devices is a safe, effective, and durable method to prevent AAA rupture and ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666250725001725

Outcomes of fenestrated-branched endovascular aortic ... There was no aortic-related mortality, aneurysm rupture, or conversions to open surgical repair. Patient survival was 100% at 6 months and 93.3% ± 16% at 1 year ...

3. jvascsurg.org jvascsurg.org/article/S0741-5214(23)02053-0/fulltext

Systematic review and meta-analysis of fenestrated or ... In 78.3% of cases, disease progression set the indication for reintervention. Technical success was estimated at 96% (95% confidence interval [ ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10830342/

Systematic review of the results of fenestrated ... Nevertheless, this review highlights the paucity of published data on the outcomes of endovascular repair of complex aneurysms in octogenarians.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0741521425016829

Long-Term Outcomes of Open versus Endovascular ... Key Findings: Repair of cAAs using F/B-devices or open repair (OR) achieved similar technical success and long-term outcomes, despite patients ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3621645/

Long-term safety and efficacy of endovascular abdominal ... Endovascular abdominal aortic aneurysm repair (EVAR) is a safe and efficacious treatment for both unruptured and ruptured abdominal aortic aneurysms.

7. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152147

Class 2 Device Recall AFX Endovascular AAA System ... Aortic Aneurysm Treatment The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA) ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10442779/

Endovascular Aneurysm Repair Devices as a Use Case for ... To assess the methodological requirements and feasibility of postmarketing device surveillance using endovascular aneurysm repair devices (EVARs).

9. tctmd.com tctmd.com/news/safe-aaa-flags-ongoing-evar-device-risk-and-urges-more-surveillance

SAFE-AAA Flags Ongoing EVAR Device Risk and Urges ... An endovascular stent graft for abdominal aortic aneurysm (AAA) that has had a troubled safety history does not meet noninferiority compared ...

10. aetna.com aetna.com/cpb/medical/data/600_699/0651.html

Endovascular Repair of Aortic Diseases The authors concluded that EVAR using contemporary devices is a safe, effective, and durable method to prevent AAA rupture and aneurysm-related death. Assuming ...