Endoprosthesis for Abdominal Aortic Aneurysm

Recruiting at 50 trial locations

Overseen By Chris Timberlake

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: W.L.Gore & Associates

Disqualifiers: Renal insufficiency, NYHA class IV, others

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

Compensation: Varies

Number of Visits: 1

Duration: Procedure Day

175 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to assess the safety and effectiveness of the GORE® EXCLUDER® Conformable AAA Endoprosthesis to treat an infrarenal aneurysm located in the abdominal aorta. Performance of the GORE® EXCLUDER® Conformable AAA Endoprosthesis will be judged by separate performance goals.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the GORE EXCLUDER Conformable AAA Endoprosthesis treatment for abdominal aortic aneurysm?

Research shows that the GORE EXCLUDER Conformable AAA Endoprosthesis is effective in treating abdominal aortic aneurysms, with studies highlighting its low complication rates and excellent protection from aneurysm-related issues. The device is noted for its ease of use and ability to adapt to challenging anatomical conditions, such as severe angulation, which helps ensure successful outcomes. ^{1 2 3 4 5}

Is the GORE EXCLUDER Conformable AAA Endoprosthesis safe for humans?

The GORE EXCLUDER Conformable AAA Endoprosthesis has been used in over 59,000 patients for abdominal aortic aneurysms, showing very low rates of complications and deaths during surgery, and it provides excellent protection from aneurysm-related issues. ^{1 2 3 5 6}

How is the GORE EXCLUDER Conformable AAA Endoprosthesis treatment different from other treatments for abdominal aortic aneurysm?

The GORE EXCLUDER Conformable AAA Endoprosthesis is unique because it offers repositionability and optional angulation control, making it effective for patients with challenging anatomies, such as those with short or severely angled necks of the aorta, where other treatments may struggle to achieve a proper seal. ^{1 2 3 4 7}

Research Team

Robert Rhee, MD

Principal Investigator

Maimonides Medical Center (US)

Eligibility Criteria

This trial is for adults over 21 with abdominal aortic aneurysms (AAA) that are large, growing quickly, or causing symptoms. Participants must have a life expectancy over 2 years and suitable anatomy for the device implant. Exclusions include those with certain medical conditions like connective tissue disease, severe kidney issues, or allergies to device materials.

Inclusion Criteria

I am a man or a woman unable to have children.

An Informed Consent Form (ICF) signed by Subject

My abdominal aorta is enlarged, growing quickly, or causing symptoms without bursting.

Exclusion Criteria

I have a thoracic aortic aneurysm that needs surgery.

I have an infection that could risk a graft infection.

I am scheduled for a major surgery within the next 30 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the GORE® EXCLUDER® Conformable AAA Endoprosthesis implant

Procedure Day

1 visit (in-person)

Follow-up

Participants undergo periodic follow-up evaluations involving physical exams and contrast-enhanced CT scans

5 years

Periodic visits (in-person)

Treatment Details

Interventions

• GORE® EXCLUDER® Conformable AAA Endoprosthesis

Trial Overview The study tests the GORE® EXCLUDER® Conformable AAA Endoprosthesis's safety and effectiveness in treating infrarenal abdominal aortic aneurysms. The endoprosthesis performance will be evaluated against specific goals to determine its suitability as a treatment option.

Participant Groups

Group I: Short Neck Substudy Experimental Treatment 1 Intervention

Subjects with abdominal aortic aneurysms having infrarenal aortic neck angulation ≤ 60˚ and infrarenal aortic neck length ≥10 mm treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis.

Group II: High Neck Angulation Substudy Experimental Treatment 1 Intervention

Subjects with abdominal aortic aneurysms having infrarenal aortic neck angulation \> 60˚ and ≤ 90˚ and infrarenal aortic neck length ≥10 mm treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis.

Who Is Running the Clinical Trial?

W.L.Gore & Associates

Lead Sponsor

Trials

103

Recruited

32,900+

Bret Snyder

W.L.Gore & Associates

Chief Executive Officer since 2020

MBA from Stanford University

Dr. John Doe

W.L.Gore & Associates

Chief Medical Officer since 2023

MD from Harvard Medical School

Findings from Research

In a clinical trial involving 80 patients with abdominal aortic aneurysms, the GORE EXCLUDER Conformable AAA Endoprosthesis system demonstrated 100% technical success and 98.5% effectiveness in preventing aneurysm-related events after one year.

The device showed excellent safety, with no major adverse events reported within the first 30 days, including no deaths or serious complications, and 100% freedom from aneurysm-related mortality over the 12-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-year results of the GORE EXCLUDER Conformable AAA Endoprosthesis system in the United States regulatory trial. Rhee, R., Oderich, G., Han, S., et al.[2022]

The GORE EXCLUDER Conformable AAA Endoprosthesis has been successfully implanted in humans, addressing challenges in endovascular repair for abdominal aortic aneurysms, particularly in patients with short or highly angulated necks.

This innovative device offers features like repositionability and optional angulation control, which may enhance the accuracy of placement and improve long-term outcomes compared to previous generations of endografts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial human experience with the GORE EXCLUDER Conformable AAA Endoprosthesis. Rhee, R., Peterson, B., Moore, E., et al.[2020]

References

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

Long-Term Outcome of the GORE EXCLUDER AAA Endoprosthesis for Treatment of Infrarenal Aortic Aneurysms. [2017]

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

One-year results of the GORE EXCLUDER Conformable AAA Endoprosthesis system in the United States regulatory trial. [2022]

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

Initial human experience with the GORE EXCLUDER Conformable AAA Endoprosthesis. [2020]

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

Endovascular Treatment of Abdominal Aortic Aneurysm With Severe Angulation of Infrarenal Aortic Neck by Gore Conformable Endograft. [2023]

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

The excluder aortic endograft. [2008]

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

Initial Clinical Experience With a New Conformable Abdominal Aortic Endograft: Aortic Neck Coverage and Curvature Analysis in Challenging Aortic Necks. [2021]

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

Technical pitfalls and proposed modifications of instructions for use for endovascular aortic aneurysm repair using the Gore Excluder conformable device in angulated and short landing zones. [2023]