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

Trial Summary

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 data supports the effectiveness of the Aortoseal Endostapling System treatment for abdominal aortic aneurysm?

The research suggests that endovascular treatments for abdominal aortic aneurysms, like the Aortoseal Endostapling System, are widely used and generally successful, with fewer complications and shorter hospital stays compared to traditional surgery. However, there are concerns about potential issues like endoleaks (leakage around the repair site) and device-related problems. ^{1 2 3 4 5}

How is the Aortoseal Endostapling System treatment different from other treatments for abdominal aortic aneurysm?

The Aortoseal Endostapling System is unique because it uses a stapling technique to secure the stent-graft in place during endovascular repair of abdominal aortic aneurysms, which may help reduce complications like endoleaks (persistent blood flow between the stent and aneurysm sac) that are common with traditional methods. ^{1 2 6 7 8}

What is the purpose of this trial?

The Aortoseal Endostapling System is indicated in patients undergoing, or having undergone, treatment of an abdominal aortic aneurysm (AAA) with an endovascular graft to provide enhanced fixation and apposition to the aorta.

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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 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 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]

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]

References

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

Midterm results of the Anson Refix endostapling fixation system for aortic stent-grafts. [2016]

2. England pubmed.ncbi.nlm.nih.gov

Endovascular treatment of abdominal aortic aneurysm. [2004]

3. Germany pubmed.ncbi.nlm.nih.gov

[Device related problems of thoracic stent-grafts]. [2022]

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

Endovascular treatment of abdominal aortic aneurysms. [2005]

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

Impact of Instructions for Use and Endoleaks On Long-Term Mortality After Treatment for Abdominal Aortic Aneurysm. [2022]

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

Vascular endostapling: new concept for endovascular fixation of aortic stent-grafts. [2014]

7. England pubmed.ncbi.nlm.nih.gov

Transradial approach for the endovascular treatment of type I endoleak after aortic aneurysm repair: a case report. [2021]

8. Poland pubmed.ncbi.nlm.nih.gov

Intra-aneurysm sac pressure measurement using a thin pressure wire during endovascular aneurysm repair. [2021]