Aortoseal for Abdominal Aortic Aneurysm

Recruiting at 3 trial locations

Overseen By Kimberly Sparkman, RN, BSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Endoron Medical

Disqualifiers: Diabetes, Hypertension, Bipolar, others

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

Compensation: Varies

Number of Visits: 30

Duration: During procedure

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Aortoseal Endostapling System. It aims to assist individuals with an abdominal aortic aneurysm (a bulge in the main blood vessel supplying blood to the belly, pelvis, and legs) who are receiving or have already received an endovascular graft (a tube placed inside the blood vessel for support). The goal is to determine if the device can better secure the graft inside the aorta. Suitable candidates have been informed they need an elective endovascular repair for their aneurysm or have already had a graft placed. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance future treatments.

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

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Aortoseal Endostapling System is safe for treating abdominal aortic aneurysm?

Research has shown that the Aortoseal Endostapling System is under close observation for safety in patients treated for abdominal aortic aneurysm (AAA). Initial safety data have been gathered through physical exams and imaging tests like X-rays and CT scans, which help identify any unwanted effects or complications.

Previous studies of treatments using small tools inside blood vessels generally report good results with fewer complications compared to traditional surgery. Although specific safety details about the Aortoseal Endostapling System are not provided, its use in clinical settings aims to strengthen weak spots in blood vessels.

If major safety concerns existed with the system, it likely wouldn't be part of a clinical trial. This suggests that researchers consider it likely safe, although individual experiences may vary. It's always important to discuss any concerns with a healthcare provider before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for abdominal aortic aneurysm involve open surgery or endovascular repair using stents and grafts. However, the Aortoseal Endostapling System is unique because it introduces a new method of securing these grafts. Instead of relying solely on the pressure fit of stents, Aortoseal uses endostaples to provide additional anchoring, potentially leading to a more secure and durable repair. Researchers are excited about this because it could reduce the risk of complications like endoleaks and improve long-term outcomes for patients.

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

Research shows that the Aortoseal Endostapling System is designed to better secure and seal medical devices used to treat abdominal aortic aneurysms (AAAs). One study found that important safety and effectiveness goals were achieved in over 97% of patients using systems like Aortoseal. This result indicates that it effectively helps keep devices in place and reduces complications related to AAAs. The system aims to lower the risk of device movement or leakage, which is crucial for patient safety. Overall, it appears promising in providing better support during and after AAA repair. ^{1 2 3 6 7}

Who Is on the Research Team?

Ross Milner, MD

Principal Investigator

Professor of Surgery Chief, Vascular Surgery and Endovascular Therapy

Jean Panneton

Principal Investigator

Professor of Surgery, Chief - Division of Vascular Surgery, Eastern Virginia Medical School

Are You a Good Fit for This Trial?

This trial is for patients with an abdominal aortic aneurysm (AAA) who are suitable for elective repair using an Endovascular Graft System, or those who have already had such a graft placed. It's not specified who can't join the trial.

Inclusion Criteria

Subjects with a previously placed endovascular graft

I have an abdominal aortic aneurysm that can be treated with a specific type of surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

The Aortoseal Endostapling System is implanted during the initial endovascular graft procedure or a secondary procedure

During procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment, with visits at 30 days, 6 months, 1 year, and yearly thereafter through 5 years

5 years

Visits at 30 days, 6 months, 1 year, and yearly thereafter

What Are the Treatments Tested in This Trial?

Interventions

• Aortoseal Endostapling System

Trial Overview The Aortoseal Endostapling System is being tested to see if it can better secure and seal endovascular grafts to the aorta in patients with AAA, either during initial treatment or after they've already received a graft.

How Is the Trial Designed?

Group I: Aortoseal Endostapling System Experimental Treatment 1 Intervention

Prospective, early feasibility, non-randomized, single arm, multi-center, open-label clinical study

Who Is Running the Clinical Trial?

Endoron Medical

Lead Sponsor

Trials

1

Recruited

30+

Published Research Related to This Trial

The Anson Refix endostapling system was successfully used in 8 patients for endovascular aneurysm repair (EVAR), with 69% of the endostaples being effectively implanted, demonstrating its feasibility for treating abdominal aortic aneurysms.

No complications such as endoleaks or endograft-related issues were observed during the 30-day follow-up, indicating a promising safety profile for this new fixation method, although further studies are needed to confirm its long-term efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vascular endostapling: new concept for endovascular fixation of aortic stent-grafts. Donas, KP., Kafetzakis, A., Umscheid, T., et al.[2014]

The case study presents the first successful use of a transradial approach for percutaneous closure of a type I endoleak in an 80-year-old man, demonstrating its feasibility in a high-risk population.

The transradial approach is highlighted as a safe and effective alternative to the traditional transfemoral method, offering reduced vascular complications and enhanced patient comfort after endovascular aortic repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transradial approach for the endovascular treatment of type I endoleak after aortic aneurysm repair: a case report. Schiattarella, GG., Magliulo, F., Laurino, FI., et al.[2021]

The study successfully measured aneurysm sac pressure (ASP) in 20 patients during endovascular aneurysm repair (EVAR) without any complications, demonstrating the safety of this new method.

Post-procedure, ASP was significantly lower than aortic pressure, indicating that this method could help assess the risk of endoleaks by monitoring pressure changes in the aneurysm sac.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-aneurysm sac pressure measurement using a thin pressure wire during endovascular aneurysm repair. Antkiewicz, M., Kuliczkowski, W., Protasiewicz, M., et al.[2021]

The Anson Refix Endostapler demonstrated a 70% success rate in implanting endostaples for abdominal aortic aneurysm treatment, with no device failures or complications such as endoleaks or migrations during an average follow-up of 18.2 months.

The procedure's delivery time improved significantly with experience, indicating that the system is feasible and safe for use in endovascular treatments, although further studies are needed to confirm its long-term effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Midterm results of the Anson Refix endostapling fixation system for aortic stent-grafts. Donas, KP., Torsello, G.[2016]

Endovascular repair of abdominal aortic aneurysms shows excellent short-term outcomes, with less than 5% of patients requiring open surgery conversions and a low annual risk of aneurysm rupture at about 1%.

While the technique is effective, there is a cumulative risk of needing secondary procedures (12% at 1 year, 24% at 2 years, and 35% at 3 years), highlighting the importance of ongoing monitoring for potential long-term complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular treatment of abdominal aortic aneurysms. Towne, JB.[2005]

In a study of 59 patients with various thoracic aortic pathologies, the 30-day mortality rate was low at 1.7%, indicating that endovascular repair can be a relatively safe option for treating these conditions.

However, the study highlighted significant device-related complications, including a case of paraplegia and several instances of endoleaks, suggesting that careful selection of stent grafts and delivery systems is crucial for successful outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Device related problems of thoracic stent-grafts]. Gawenda, M., Brunkwall, J.[2022]

Endovascular repair of abdominal aortic aneurysms is associated with complications such as endoleak, which occurs in a significant number of patients, raising concerns about the long-term effectiveness of the treatment.

Despite the risks, endovascular repair may provide some protection against aneurysm rupture, but patients require lifelong imaging surveillance and potential further interventions to monitor their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular treatment of abdominal aortic aneurysm. Gorham, TJ., Taylor, J., Raptis, S.[2004]

In a study of 278 patients treated for abdominal aortic aneurysm, endovascular aortic repair showed a cumulative survival rate of 78.6%, but certain risk factors like hemodialysis and type I or III endoleaks significantly increased the risk of all-cause mortality.

The analysis identified that following proper instructions for use during endovascular repair can reduce the risk of endoleaks, and suggested that open repair may be a better option for improving long-term survival in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Instructions for Use and Endoleaks On Long-Term Mortality After Treatment for Abdominal Aortic Aneurysm. Sato, H., Fukada, J., Tamiya, Y.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06586021

Evaluation of the Aortoseal™ for Sealing and Fixation ... Study Overview. Brief Summary. The Aortoseal Endostapling System is indicated in patients undergoing, or having undergone, treatment of an abdominal aortic ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4128641/

Endovascular treatment of abdominal aortic aneurysms Indeed, a retrospective analysis of Medicare beneficiaries undergoing AAA repair in the USA showed that EVAR accounted for 77% of intact AAA repairs in 2008. In ...

3. withpower.com withpower.com/trial/phase-aortic-aneurysm-1-2024-6941d

Aortoseal for Abdominal Aortic Aneurysm What data supports the effectiveness of the Aortoseal Endostapling System treatment for abdominal aortic aneurysm? The research suggests that endovascular ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0741521414002468

Outcome of the pivotal study of the Aptus endovascular ... Overall, the primary safety and effectiveness end points were met in 98.1% and 97.4% of the subjects, respectively. Aneurysm-related mortality was 0.6%, with ...

5. clinicaltrial.be clinicaltrial.be/en/details/451282?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Evaluation of the Aortoseal™ for Sealing and Fixation of... Discover the latest clinical trials, research studies, and groundbreaking medical advances with our comprehensive, user-friendly platform.

6. onderzoekmetmensen.nl onderzoekmetmensen.nl/en/node/57055/pdf

Feasibility Evaluation of the Aortoseal Endostapling System for ... initialclinical safety data for the Aortoseal Endostapling System ... Abdominal aortic aneurysm (AAA) is a focal enlargement of the abdominal aorta ... outcomes ...

7. ahajournals.org ahajournals.org/doi/10.1161/JAHA.123.032715

Saccular and Fusiform Abdominal Aortic Aneurysms ... Saccular abdominal aortic aneurysms (AAAs) are considered to be at higher risk of rupture than fusiform AAAs, but not much is known about ...