Using modified endovascular grafts to treat abdominal aortic 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 study aims to evaluate the safety and effectiveness of physician modified endovascular grafts (PMEG) and specific company-manufactured devices for treating juxtarenal aortic aneurysms in patients who are not suitable candidates for traditional open surgery. The study also seeks to validate a patient-specific, 3-D printed aortic template as a tool for surgical planning in fenestrated endografting. By focusing on patients with limited treatment options, the research addresses a critical need in managing this life-threatening condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

All patients must meet all of the following inclusion criteria to be eligible for enrollment into this study:

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: Abdominal aortic aneurysm \>5.5 cm in diameter, Aneurysm has increased in size by 0.5 cm in last 6 months, Maximum diameter of aneurysm exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment
5. Patient has appropriate iliac/femoral artery anatomy for access, with or without the use of a conduit, that will allow endovascular access with the physician modified endovascular graft.
6. Patient has a suitable non-aneurysmal proximal aortic neck length 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 \>15 mm. 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 32mm, 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 \< 60º
11. Patient must be willing to comply with all required follow-up exams

Exclusion Criteria:

Patients that meet ANY of the following are not eligible for enrollment into the study:

1. Patient has a mycotic aneurysm or has an active systemic 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 planned within +/- 30 days of the AAA repair.
4. Patient has history of 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 a known allergy or intolerance stainless steel or gold
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. Subject is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site

Where it's running

• Harborview Medical Center
  Seattle, Washington, United States Recruiting

Study contacts

• Principal investigator: Benjamin W Starnes, MD — University of Washington
• Study coordinator: Allison Larimore, MSN, RN
• Email: alari@uw.edu
• Phone: 206-744-8257

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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.