ChEVAS for Abdominal Aortic Aneurysm

(ChEVAS One Trial)

Recruiting at 26 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called the Chimney Endovascular Aortic Sealing (ChEVAS) System for individuals with complex abdominal aortic aneurysms (AAA), which are dangerous bulges in the main blood vessel in the stomach area. The trial aims to determine how effectively this system can repair these aneurysms without open surgery, using a special type of stent (a tube that keeps vessels open). Individuals with a large or rapidly growing abdominal aortic aneurysm might be suitable candidates for this trial. Those affected by such an aneurysm that impacts daily life might consider participating. As an unphased trial, this study provides an opportunity to explore innovative treatment options that could enhance quality of life.

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 prior data suggests that the ChEVAS System is safe for endovascular repair of complex abdominal aortic aneurysms?

Studies have shown that the Chimney Endovascular Aortic Sealing (ChEVAS) System is generally safe for treating complex abdominal aortic aneurysms. One study confirmed over seven years that this technique is both safe and effective. Another study found that high-risk patients tolerate the procedure well, with acceptable outcomes.

While these studies suggest ChEVAS is safe, individual experiences can vary. Reports indicate some risks, including illness and death, similar to those of other procedures.

Overall, research supports the safety of ChEVAS. However, as with any medical procedure, discussing potential risks and benefits with a healthcare provider is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The ChEVAS System is unique because it combines the Nellix System with parallel branch chimney stents to treat abdominal aortic aneurysms near the kidneys or other major abdominal organs. Unlike traditional open surgery or standard endovascular aneurysm repair (EVAR), which may not effectively manage complex aneurysms close to vital arteries, ChEVAS offers a minimally invasive approach that promises better compatibility with these challenging cases. Researchers are excited about this treatment because it could expand the range of patients eligible for less invasive procedures and potentially improve outcomes by sealing the aneurysm more reliably while preserving blood flow to vital organs.

What evidence suggests that the ChEVAS System is effective for abdominal aortic aneurysms?

Studies have shown that the Chimney Endovascular Aortic Sealing (ChEVAS) System, which participants in this trial will receive, provides good long-term results for patients with complex abdominal aortic aneurysms. It has successfully treated high-risk patients, demonstrating positive outcomes over time. Research indicates that the ChEVAS procedure uses special tubes, called stents, to seal aneurysms and help prevent them from bursting. In simpler terms, it helps stop the blood vessel from breaking open, which poses a serious risk. Early findings suggest that this treatment holds promise for complicated cases. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

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 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 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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04252573

Chimney EndoVascular Aneurysm Sealing Of New ... The outcome at one-year post index procedure will be measured by the proportion of subjects that experience freedom from abdominal aortic aneurysm rupture and ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0741521424009352

Long-term outcomes of chimney endovascular aneurysm ... Chimney endovascular aortic repair showed acceptable to good long-term outcomes in a series of high-risk patients with complex abdominal aortic aneurysms.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11721662/

Long-Term Outcomes of Endovascular Aortic Repair with ... Long-term outcomes of endovascular aortic repair with parallel chimney or periscope stent grafts for ruptured complex abdominal aortic aneurysms.

4. evtoday.com evtoday.com/articles/2019-nov/chevas-exploring-off-the-shelf-repair-of-thoracoabdominal-aneurysms

ChEVAS: Exploring Off-the-Shelf Repair of ... Early results of endovascular aneurysm sealing with chimney grafts to treat juxtarenal and suprarenal abdominal aortic aneurysms. J Vasc Surg. 2019;70:43-52 ...

5. jvascsurg.org jvascsurg.org/article/S0741-5214(21)00488-2/fulltext

Outcomes of chimney/snorkel endovascular repair for ... ChEVAR for symptomatic and ruptured AAAs can be performed with acceptable rates of morbidity and mortality. Long-term data are needed to determine the ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38604322/

Long-term outcomes of chimney endovascular aneurysm ... The 7-year results of chimney endovascular aortic repair procedures performed in our center confirm the long-term safety and effectiveness of this technique.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2666688X25000292

Long Term Follow Up of Abdominal Aortic Aneurysms ... This study aimed to compare the long term outcomes of EVAS compared with standard endovascular aneurysm repair (EVAR).