Using modified endovascular grafts to treat abdominal aortic aneurysms

Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysm: An Investigator Initiated Study

This study is testing a new type of graft to see if it can safely and effectively treat abdominal aortic aneurysms in patients who can’t have regular surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Washington (Academic / other)
• Locations: 1 site (Seattle, Washington)
• Trial ID: NCT01538056 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include males and non-pregnant females over 18 with juxtarenal abdominal aortic aneurysms that meet specific size and growth criteria.

Not a fit: Patients with aneurysms that do not meet the inclusion criteria or those with significant comorbidities that preclude endovascular access may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with complex abdominal aortic aneurysms.

How similar studies have performed: Other studies have shown promising results with similar endovascular approaches, indicating potential for success in this novel application.

Eligibility criteria

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 this trial is running

Seattle, Washington

• 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

Conditions Abdominal Aortic Aneurysms; AAA