Physician-Modified Endovascular Grafts for Juxtarenal Aneurysms

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 interventional study examines the use of a physician-modified endovascular graft (PMEG) to repair juxtarenal abdominal aortic aneurysms. Participants will undergo an Endovascular Aneurysm Repair with a PMEG and will have follow-up visits at discharge, 1 month, 6 months, 12 months, and annually up to 5 years to monitor safety and graft performance. The PMEG is an investigational device designed to preserve blood flow to renal and visceral arteries through fenestrations and adjunctive branch grafts. The study collects data on feasibility, device-related safety, and effectiveness in real-world surgical settings. Enrollment criteria include adults with specific aneurysm characteristics or rupture risk who have suitable access vessels.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patient is ≥ 18 years of age
2. Patients who are male or non-pregnant female (females of child bearing potential must have a negative pregnancy test prior to enrollment into the study)
3. Patient or Legally Authorized Representative has signed an Institutional Review Board (IRB) approved Informed Consent Form
4. Patient has a juxtarenal abdominal aortic aneurysm that meets at least one of the following:

   1. An aneurysm with a maximum diameter of ≥ 5.5 cm for male (≥ 5.0 cm for female) or 2 times the normal diameter just proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline) measurements
   2. Aneurysm with a history of growth \> 0.5 cm in 6 months
   3. Saccular aneurysm deemed at significant risk for rupture
   4. Symptomatic aneurysm
   5. Ruptured aneurysm
5. Patient has patent iliac or femoral arteries, with or without the use of conduit, that will allow endovascular access with the physician modified endovascular graft.
6. Patient has a suitable non-aneurysmal proximal aortic neck of ≥ 2 mm inferior to the most distal renal artery ostium.
7. Patient has a suitable non-aneurysmal distal iliac artery length (seal zone) of ≥ 15mm. The resultant repair should preserve patency in at least one hypogastric artery.
8. Patient has a suitable non-aneurysmal proximal aortic neck diameter between 20 and 32 mm, averaged across the diameters at the Celiac, SMA, at the lowest patent renal artery and at the midpoint of the renal arteries.
9. Patient has suitable non-aneurysmal distal common iliac diameters between 8 and 20 mm.
10. Patient has juxtarenal aortic neck angulation ≤ 60°
11. Target branch vessel diameter ≥ 5 mm.
12. Patient must be willing to comply with all required follow-up exams.

Exclusion Criteria:

1. Patient has a mycotic aneurysm or has an active systemic or local infection that may increase the risk of endovascular infection
2. Patient has unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina)
3. Patient has a major surgical or interventional procedure, not related to the endovascular repair, planned within +/- 30 days of the AAA repair.
4. Patient has history of an aortopathic connective tissue disease (e.g. Marfan's or Ehler's-Danlos syndrome).
5. Patient has a known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment.
6. Patient has known allergy or intolerance to stainless steel, nitinol or gold (gold-coated tungsten).
7. Patient has a body habitus that would inhibit X-ray visualization of the aorta
8. Patient has a limited life expectancy of less than 1 year
9. Patient is currently participating in another investigational device or drug clinical trial
10. 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.
11. Thrombus or excessive calcification within the neck of the aneurysm
12. Branch vessel stenosis ≥ 80%
13. Patient treatable on label with FDA approved EVAR or FEVAR device and can wait for device availability.
14. Subject is willing and eligible to enroll in a manufacturer-sponsored study at the investigational site, or the subject is willing and eligible to participate in a study with a manufacturer-made device at another institution.

Where it's running

• University of Utah Hospital
  Salt Lake City, Utah, United States Recruiting

Study contacts

• Principal investigator: Cali Johnson, MD, EdD — University of Utah
• Study coordinator: Julie Hales, MSN, RN, CCRC
• Email: Julie.Hales@hsc.utah.edu
• Phone: 801-587-1450

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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.