Aortoseal for Abdominal Aortic Aneurysm

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen by Ross Milner, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Endoron Medical

Disqualifiers: Diabetes, Hypertension, Bipolar, others

No Placebo Group

Trial Summary

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.

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}

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.

Trial 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 (Device)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Sentara Health Research Center Norfolk, VA

The University of Chicago Chicago, IL

The University of Texas Southwestern Medical Center Dallas, TX

Baylor Scott & White The Heart Hospital - Plano Plano, TX

Who Is Running the Clinical Trial?

Endoron Medical Lead Sponsor

References

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

Midterm results of the Anson Refix endostapling fixation system for aortic stent-grafts. [2016] To report the midterm results of a new vascular endostapling system in the endovascular treatment of abdominal aortic aneurysms (EVAR).

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

Endovascular treatment of abdominal aortic aneurysm. [2004] Endovascular repair of abdominal aortic aneurysm has become widely used. Supporters claim high success rates, few complications and a dramatically reduced hospital stay. However, endoleak, endotension and reports of endoprosthesis rupture are causes of concern.

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

[Device related problems of thoracic stent-grafts]. [2022] The outcome of the endovascular repair of abdominal aortic aneurysms seems to be device related. The presented study evaluated the outcome of endovascular procedure in cases of thoracic aortic pathology according to the implanted thoracic stent graft devices.

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

Endovascular treatment of abdominal aortic aneurysms. [2005] Endovascular treatment of abdominal aortic aneurysms is a rapidly evolving technique that has gained broad acceptance in the treatment of patients with abdominal aortic aneurysms.

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] We reported the clinical outcomes after open repair and endovascular aortic repair for abdominal aortic aneurysm and analyzed the risk factors for all-cause mortality and endoleak after endovascular aortic repair.

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

Vascular endostapling: new concept for endovascular fixation of aortic stent-grafts. [2014] To evaluate the feasibility of a new vascular endostapling system in treating infrarenal abdominal aortic aneurysms using commercially available endografts.

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] Endovascular repair of aortic aneurysms (EVAR) is obtained through the positioning of an aortic stent-graft, which excludes the aneurysmatic dilation. Type I endoleak is the most common complication, and it is caused by an incompetent proximal or distal attachment site, causing the separation between the stent-graft and the native arterial wall, and in turn creating direct communication between the aneurysm sac and the systemic arterial circulation. Endoleak occurrence is associated with high intrasac pressures, and requires a quick repair to prevent abdominal aortic aneurysm rupture.

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

Intra-aneurysm sac pressure measurement using a thin pressure wire during endovascular aneurysm repair. [2021] An endoleak is a typical complication of endovascular aneurysm repair (EVAR). It is characterized by persistent blood flow between a stent graft and the aneurysm sac. Usually, it can be visualized during primary EVAR, but in many cases, this remains impossible. Therefore, other methods of endoleak assessment are urgently needed. The measurement of aneurysm sac pressure (ASP) seems to be a promising direction of research in this area.