Evaluating outcomes of endovascular abdominal aortic aneurysm repair

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, randomized, multi-center study aims to assess the outcomes of contemporary endovascular abdominal aortic aneurysm (EVAR) devices in a real-world population. Patients will be randomly assigned to two different device cohorts and their outcomes will be compared across primary endpoints. Follow-up evaluations will occur at discharge, and at 1, 6, 12 months, and annually for up to 5 years to monitor long-term results.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult age 21 and older
* Subjects with minimum of 2 year life expectancy
* Subjects have signed the informed consent document
* Subjects with unruptured infrarenal AAA who are assessed by the Investigator to be eligible for endovascular Abdominal Aortic Aneurysm Repair with the trial devices.
* Patient must be able and willing to comply with all required follow-up exams.

Exclusion Criteria:

* Currently participating in another trial where the primary endpoint has not been reached yet.
* Known allergy to any of the device components
* Pregnant (females of childbearing potential only)
* Known connective tissue disorders
* Known active infection
* Subjects with pre-existing EVAR, i.e., in need of repair/intervention of a previously failed EVAR.
* Patient has other medical, social, or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations.

Where it's running

• University of Arizona
  Tucson, Arizona, United States Recruiting
• Washington Regional Medical Center
  Fayetteville, Arkansas, United States Recruiting
• Central Arkansas Veterans Healthcare System
  Little Rock, Arkansas, United States Recruiting
• The Regents of the University of California, San Diego
  La Jolla, California, United States Recruiting
• Veterans Affairs San Diego Healthcare System
  San Diego, California, United States Recruiting
• MedStar Washington Hospital Center
  Washington D.C., District of Columbia, United States Recruiting

Study contacts

• Principal investigator: Sean Lyden, MD — The Cleveland Clinic
• Study coordinator: Noel DeSisto
• Email: ndesisto@endologix.com
• Phone: 864-270-8524

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Heli-FX EndoAnchor system in abdominal aortic aneurysm patients in China

  This study tests whether the Heli-FX EndoAnchor device can safely and effectively help seal and fix AAA patients at high risk of endoleaks or migration after repair.

  Recruiting Medtronic Cardiovascular · Beijing · NCT07754318

• TUVA BX and iCover stent grafts used in BEVAR for complex aortic aneurysms

  This study looks at whether the TUVA BX and iCover stent grafts used during BEVAR procedures are safe and perform well in real-world patients with complex abdominal or thoracoabdominal aneurysms.

  Recruiting JOTEC GmbH · Heerlen · NCT07540507

• Retreatment with the Nectero EAST System for abdominal aortic aneurysm

  This will try retreatment with the Nectero EAST System to repair infrarenal abdominal aortic aneurysms in adults who previously received the device under the initial protocol.

  Recruiting at 2 sites Nectero Medical, Inc. · Randwick, New South Wales and 1 other locations · NCT07505082

• Abdominal CT offered alongside lung screening for people who have smoked

  We will test whether mentioning a possible extra abdominal CT in the lung screening invitation changes whether people aged 55–70 who have ever smoked attend their lung screening appointment.

  Recruiting University of Cambridge · Hull · NCT07171190

• Observational registry for patients treated with GORE® endovascular devices for abdominal aortic aneurysms

  This study is tracking patients who have been treated with GORE® devices for abdominal aortic aneurysms to see how they do over the next 10 years.

  Recruiting at 87 sites W.L.Gore & Associates · Little Rock, Arkansas and 89 other locations · NCT06218875

• Ankura II AAA Endovascular Graft System for Abdominal Aortic Aneurysm

  This trial tests whether the Ankura II stent grafts can safely and effectively treat infrarenal abdominal aortic aneurysms in adults.

  Recruiting Lifetech Scientific (Shenzhen) Co., Ltd. · Pleven · NCT07754240

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.