Endoprosthesis for Abdominal Aortic Aneurysm

Not currently recruiting at 52 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, the GORE® EXCLUDER® Conformable AAA Endoprosthesis, to determine its safety and effectiveness in treating abdominal aortic aneurysms (a bulge in the main artery that carries blood from the heart to the rest of the body). The study focuses on individuals with a specific type of aneurysm that hasn't ruptured but is either large, growing quickly, or causing symptoms. Participants should have aneurysms with certain size and shape characteristics and must be able to undergo the procedure and follow-up. The trial includes two groups: one for individuals with a certain neck angle in their aneurysm and another for those with a different neck angle. As an unphased trial, this study allows participants to contribute to the development of innovative treatments for aneurysms.

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 prior data suggests that the GORE® EXCLUDER® Conformable AAA Endoprosthesis is safe for treating abdominal aortic aneurysms?

Research has shown that the GORE® EXCLUDER® Conformable AAA Endoprosthesis is generally safe for treating certain types of abdominal aortic aneurysms, which are bulges in the large artery that carries blood from the heart. In one study, researchers monitored patients for five years, and the results indicated that the device was safe and effective for aneurysms in specific areas of the aorta. No unexpected safety issues arose during this period.

Additionally, another study with one-year results also supports its safety, showing positive outcomes for patients. These findings suggest that the treatment is well-tolerated. Such long-term data encourages those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The GORE® EXCLUDER® Conformable AAA Endoprosthesis is unique because it offers a new approach to treating abdominal aortic aneurysms, particularly in patients with challenging anatomy. Unlike traditional endovascular stent grafts, this device is designed to conform to short or highly angulated aortic necks, which can be difficult to treat with standard options. Researchers are excited about this treatment because its flexibility and adaptability could lead to better sealing and fixation, potentially reducing the risk of complications and improving patient outcomes.

What evidence suggests that the GORE® EXCLUDER® Conformable AAA Endoprosthesis is effective for treating abdominal aortic aneurysms?

Studies have shown that the GORE® EXCLUDER® Conformable AAA Endoprosthesis effectively treats abdominal aortic aneurysms, which are bulges in the main blood vessel in the belly. In one study, only 11.3% of patients required another procedure after receiving this device, and only 10.3% experienced their aneurysm growing by 5mm or more over five years. Another study found that after one year, the device performed well and met the trial's goals. In this trial, participants will receive treatment with the GORE® EXCLUDER® Conformable AAA Endoprosthesis in different substudies based on specific aneurysm characteristics. These results suggest that the endoprosthesis can safely manage and control aneurysms in the abdominal aorta. ^{1 2 3 5 6}

Who Is on the Research Team?

Robert Rhee, MD

Principal Investigator

Maimonides Medical Center (US)

Are You a Good Fit for This Trial?

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.

You have a history of using drugs in a harmful way.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40464725/

Five-year pivotal trial outcomes of the Gore Excluder ...

At 5 years, 15 patients died, 12 were lost to follow-up, and for 47 of the 53 remaining patients, 5-year follow-up data was available. The mean ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S074152142500998X

Five-year pivotal trial outcomes of the Gore Excluder ...

Reinterventions occurred in 11.3%, and abdominal aortic aneurysm sac expansion ≥5 mm occurred in 10.3%; there were no differences between ≥10 mm ...

3.

goremedical.com

goremedical.com/node/605

One-year results of the GORE EXCLUDER Conformable ...

ABSTRACT. Objective: To report the 1-year clinical outcomes from the GORE EXCLUDER Conformable AAA Endoprosthesis system in the US regulatory trial.

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02489539?utm_source=trialradar

NCT02489539 | Assessment of the GORE® EXCLUDER® ...

The purpose of the study is to assess the safety and effectiveness of the GORE® EXCLUDER® Conformable AAA Endoprosthesis to treat an infrarenal aneurysm ...

5.

jvascsurg.org

jvascsurg.org/article/S0741-5214(24)01884-6/fulltext

Three-year outcomes of a US pivotal trial substudy for ...

The study enrolled patients with abdominal aortic aneurysms (AAA) with a minimum proximal landing zone ≥10 mm and proximal neck angulation of ≤60 degrees.

6.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf20/P200030S014B.pdf

Summary of Safety and Effectiveness Data (SSED)

The GORE EXCLUDER Conformable AAA Endoprosthesis (EXCC Device) provides endovascular treatment of infrarenal abdominal aortic aneurysms (AAA).