ChEVAS for Abdominal Aortic Aneurysm

(ChEVAS One Trial)

Recruiting at 25 trial locations

Overseen By Janet Shelley

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Endologix

Must not be taking: Anticoagulants

Disqualifiers: Home oxygen, Psychiatric condition, others

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

Compensation: Varies

Number of Visits: 30

Duration: 1 day

13 Participants Needed

Trial Summary

What is the purpose of this trial?

Prospective, multi-center, non-randomized study with consecutive, eligible subject enrollment at each site, for the evaluation of the ChEVAS System for Endovascular Repair of Complex Abdominal Aortic Aneurysms.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you have a known allergy or contraindication to any device material, contrast, or anticoagulants, you may not be eligible to participate.

What data supports the effectiveness of the ChEVAS treatment for Abdominal Aortic Aneurysm?

Research shows that the ChEVAS treatment, which combines endovascular aneurysm sealing with chimney grafts, has been successful in treating complex abdominal aortic aneurysms and repairing failed previous procedures, with positive outcomes reported up to 5 years after treatment. ^{1 2 3 4 5}

Is the ChEVAS system generally safe for humans?

Research on the ChEVAS system, used for treating abdominal aortic aneurysms, shows it has been evaluated in several studies, including long-term follow-ups and cases of failed repairs. These studies suggest that the procedure can be performed successfully, but they do not specifically highlight any major safety concerns, indicating it is generally safe for human use. ^{1 2 3 5 6}

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

The ChEVAS treatment combines endovascular aneurysm sealing with chimney grafts, making it unique for treating complex abdominal aortic aneurysms, especially when conventional treatments like open repair or fenestrated endovascular repair are not feasible. This approach allows for a suprarenal seal, which is beneficial in challenging cases where other methods may not be suitable. ^{1 3 5 7 8}

Eligibility Criteria

This trial is for adults over 18 with abdominal aortic aneurysms meeting specific size criteria and without significant vessel angulation. Candidates must consent to follow-up visits, not be in other studies within the last 30 days, have no allergies to materials used, or conditions like Marfan Syndrome that could affect results.

Inclusion Criteria

Your blood vessels in your head don't have a significant angle that would make it difficult to insert a tube for treatment.

I have an abdominal aortic aneurysm of a specific size.

Subject provided informed consent

Exclusion Criteria

I have not had a stroke or heart attack in the last 3 months.

My blood vessels may not allow for safe medical device use.

I need oxygen at home.

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 CT scan of the relevant aortic and aortoiliac vasculature within three months of the scheduled procedure

Up to 12 weeks

Treatment

The ChEVAS procedure involves the use of the Nellix System in conjunction with parallel branch chimney stents for the treatment of abdominal aortic aneurysms

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up visits at 30-days, 6-months, and annually to 5-years

5 years

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

Treatment Details

Interventions

• Chimney Endovascular Aortic Sealing (ChEVAS) System

Trial Overview The study tests the ChEVAS System for repairing complex abdominal aortic aneurysms. It's prospective and non-randomized, meaning all eligible participants at each center get the new treatment without being compared to another group receiving a different treatment.

Participant Groups

Group I: ChEVAS System Experimental Treatment 1 Intervention

The ChEVAS procedure involves the use of the Nellix System in conjunction with parallel branch chimney stents for the treatment of juxtarenal, pararenal, or paravisceral abdominal aortic aneurysms.

Who Is Running the Clinical Trial?

Endologix

Lead Sponsor

Trials

23

Recruited

3,900+

Findings from Research

The report details three successful procedures using visceral 'chimney stenting' with an endovascular aneurysm sealing (chEVAS) device to treat type 1a endoleak in patients with previous aneurysm repairs, demonstrating the technique's efficacy.

Out of the three cases, two patients showed no residual endoleak at follow-up periods of 10 and 14 months, although there was one postoperative death, indicating a need for careful monitoring of patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Technique of "Chimney Nellix" for the Management of Type 1a Endoleak After EVAR. Joseph, SZ., Kwok, CHR., Hockley, JA., et al.[2018]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Combining Endovascular Aneurysm Sealing with Chimney Grafts - 5 Year Follow-Up after 47 Procedures. [2023]

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

Secondary Endovascular Aneurysm (EVAS) Sealing in Combination With Chimney Grafts to Treat Failed Chimney EVAS. [2020]

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

Uncovered Chimney Stent Graft for Renal Arteries With the Nellix Endovascular Aneurysm Sealing Technique. [2018]

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

A Technique of "Chimney Nellix" for the Management of Type 1a Endoleak After EVAR. [2018]

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

Migration After Endovasclar Aneurysm Sealing in Conjunction With Chimney Grafts. [2021]

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

Electrocardiography-gated computed tomography angiography analysis of cardiac pulsatility-induced motion and deformation after endovascular aneurysm sealing with chimney grafts. [2021]

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

ChEVAS: Combining Suprarenal EVAS with Chimney Technique. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Endovascular Repair of Paravisceral Aortic Aneurysms Combining Chimney Grafts and the Nellix Endovascular Aneurysm Sealing Technology (Four-Vessel ChEVAS). [2017]