Assessment of the GORE EXCLUDER Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms

  • STATUS
    Recruiting
  • End date
    Dec 31, 2026
  • participants needed
    190
  • sponsor
    W.L.Gore & Associates
Updated on 15 June 2021
aortic aneurysm

Summary

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.

Description

The study design is a prospective, nonrandomized, international, multicenter study comprised of two parallel substudies. The total subject population will be 190 subjects with 80 subjects assigned to the Short Neck Substudy and 110 subjects to the High Neck Angulation Substudy.

This clinical study will include fifty-six sites in the US. Each enrolled subject will undergo periodic follow-up evaluations involving physical exams and contrast-enhanced computed tomography (CT) scans at specific, protocol-defined intervals for a period of five years following the GORE EXCLUDER Conformable AAA Endoprosthesis implant. Each Substudy will be evaluated and reported independently from each other according to the Safety and Effectiveness Endpoints. No comparative analyses between these substudies are planned.

Details
Condition Abdominal aortic aneurysm
Treatment GORE® EXCLUDER® Conformable AAA Endoprosthesis
Clinical Study IdentifierNCT02489539
SponsorW.L.Gore & Associates
Last Modified on15 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

AAA meeting any of the following criteria
Maximum diameter 50 mm
Rapid growth (>5 mm in a 6 month period)
Non-ruptured AAA presenting with clinical symptoms
Adequate anatomy to receive the GORE EXCLUDER Conformable AAA Endoprosthesis
including
Adequate iliac / femoral access
Infrarenal aortic neck diameter 16-32 mm
Infrarenal aortic neck length 10 mm
Aortic neck angle 90
Distal iliac artery seal zone 10 mm
Iliac artery diameter 8-25 mm
An Informed Consent Form (ICF) signed by Subject
Male or infertile female
Able to comply with Protocol requirements including following-up
Life expectancy > 2 years
Age 21 years

Exclusion Criteria

Mycotic or ruptured aneurysm
Known concomitant thoracic aortic aneurysm which requires surgical intervention
Renal insufficiency defined as creatinine > 2.5 mg/dL or patient undergoing dialysis
New York Heart Association (NYHA) class IV
Aneurysmal, dissected, heavily calcified, or heavily thrombosed landing zone(s)
Severely tortuous or stenotic iliac and / or femoral arteries
Patient has body habitus or other medical condition which prevents adequate delineation of the aorta
Participating in another investigational device or drug study within 1 year of treatment
Systemic infection which may increase the risk of endovascular graft infection
Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome
Planned concomitant surgical procedure or major surgery within 30 days of treatment date
Known history of drug abuse
Known sensitivities or allergies to the device materials
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note