New graft technique offers hope for patients with complex aneurysms
NCT ID NCT01538056
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether specially modified endovascular grafts can safely treat juxtarenal aortic aneurysms—a type of bulge in the main belly artery near the kidney arteries. The grafts are either modified by the doctor or made by a company, and are used in patients who have few other options. The trial aims to enroll 500 adults and will check for safety and success in delivering the graft without leaks or other problems.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Fenestrated endovascular graft (physician-modified or company-manufactured)
- What this could lead to
- If successful, this could provide a safer, less invasive treatment option for patients with complex aortic aneurysms who have few alternatives.
- What could go wrong
- This is an early-stage study without a control group, so results may not apply broadly. Risks include major adverse events like endoleaks or graft migration.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 500 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
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Mar 2011
- Expected to finish
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Jan 2055
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Harborview Medical Center
RECRUITINGSeattle, Washington, 98104, United States
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