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Physician Modified Endograft for Complex Aortic Aneurysm Repair

This study is testing a special way to fix complex aortic aneurysms (a bulging in your body's main artery) using a "physician modified endograft." This involves a doctor custom-fitting a device (made from Cook Medical devices like Zenith TX2, Zenith Alpha Thoracic, and Zenith Fenestrated AAA Endovascular Grafts) during surgery to repair the aneurysm. This approach is for high-risk patients whose aneurysms involve arteries going to the kidneys or intestines, and who can't use standard treatments. The study aims to see how safe this method is within 30 days and how well it works after one year. We plan to enroll 40 participants, but the current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 40 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety for 30 days or during hospitalization, and for effectiveness for one year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05339061

Physician Modified Endograft For Complex Aortic Aneurysm Repair

Recruiting
NAAges 18+InterventionalTreatment
University of California, Davis
~40 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:Endovascular Treatment of Complex abdominal or Thorocoabdominal aneurysms (TAAA).

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The Primary Safety Endpoint (Freedom from major adverse events [MAE])
Measured over At 30 days or during hospitalization if this exceeds 30 days.
+1 more outcome measured

Conditions

Complex Abdominal Aortic Aneurysm
Juxtarenal Aortic Aneurysm
Pararenal Aortic Aneurysm
Thoracoabdominal Aortic Aneurysm

Explore related trials

Abdominal Aortic AneurysmAneurysm of pararenal aortaJuxtarenal aortic aneurysmThoracoabdominal aortic aneurysm

Where it's being run

1 sites across 1 states
California1

Who to contact

Sina Zarrintan, MD
[email protected]
8582463003
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Aortic aneurysm with diameter ≥ 5.5cm
Aortic aneurysm with a history of growth ≥0.5cm in the last 6 months
Symptomatic aortic aneurysm 5. Cannot be treated with a currently available non-modified approved device 6. High risk for open surgical repair based on any of the factors below:

What this trial measures

  • The Primary Safety Endpoint (Freedom from major adverse events [MAE])At 30 days or during hospitalization if this exceeds 30 days.

    Major adverse events include death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke.

  • Primary effectiveness endpointThe primary effectiveness endpoint is the proportion of study subjects with treatment success at 1 year.

    Treatment success is defined as a composite of technical success and freedom from the following: * Aneurysm enlargement \[i.e., \>5mm as compared to any previous CT measure using orthogonal (i.e, perpendicular to the centerline) measurements\] * Aneurysm rupture * Aneurysm-related mortality * Conversion to open repair * Secondary intervention for migration, Type I and III endoleaks, device integrity failure (e.g., fracture), and patency-related events (i.e., device component stenosis or occlusion and embolic events)