RecruitingNot ApplicableNCT05339061

Physician Modified Endograft For Complex Aortic Aneurysm Repair

A Single-Arm, Single-Center, Non-Randomized, Prospective Clinical Study to Evaluate the Safety and Effectiveness of Physician Modified Endograft for Complex Abdominal and Thoracoabdominal Aortic Aneurysm Repair

Sponsor

University of California, Davis

Enrollment

40 participants

Start Date

Mar 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Summary

The physician modified endograft is intended for treating complex, pararenal, juxtarenal and thoracoabdominal aortic aneurysms requiring coverage of renal arteries, the superior mesenteric artery or the celiac trunk in high-risk patients who do not have an option for endovascular repair with an FDA approved endograft and have an appropriate anatomy. There will be one investigational site with a total of 40 subjects to be enrolled. Time to complete enrollment will be 24 months and the subject follow-up time will be five years from last subject enrollment. The primary safety endpoint is freedom from major adverse events (MAE) at 30 days or during hospitalization if this exceeds 30 days. The primary effectiveness endpoint is the proportion of study subjects with treatment success at one year. The subjects will be followed at one month, six months, one year, and yearly thereafter for a total period of five years. Subjects will be followed up clinically for life. Clinical exam follow up may be phone or video visit with CT scan evaluation and duplex ultrasound as needed. The proportion of treatment group subjects that achieve and maintain treatment success annually to five years will be investigated.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a technique where surgeons modify an existing endovascular graft to treat complex aortic aneurysms — dangerous bulges in the main blood vessel of the body. These are cases where the aneurysm involves arteries supplying the kidneys or other abdominal organs, making standard devices unsuitable. You may be eligible if... - You are over 18 years old - You have a complex, juxtarenal, pararenal, or thoracoabdominal aortic aneurysm meeting size or growth criteria - You cannot be treated with a standard commercially available device - You are considered high risk for open surgery due to age, prior surgeries, or heart/lung conditions - Your blood vessels allow safe endovascular access - Your aorta has sufficient healthy vessel above and below the aneurysm for a seal You may NOT be eligible if... - Your aneurysm is infected (mycotic) - Your aneurysm has ruptured and requires emergency repair - You have an active infection that could infect the graft - You have a known allergy to anticoagulants or contrast dye that cannot be pre-treated - You have a connective tissue disease such as Marfan's syndrome - You have active cancer with a life expectancy of less than 2 years - You have unstable angina or a bleeding/clotting disorder Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEndovascular Treatment of Complex abdominal or Thorocoabdominal aneurysms (TAAA).

Modification * Deploy the graft on the sterile, surgical table * Mark out on the graft the locations of the fenestrations on the graft adjusting as necessary * Using handheld electrocautery, fashion the fenestration in the appropriate location on the moistened graft material in order to prevent inadvertent progression of the fenestration size * If the fenestration is going to remain as such, then a snare is used to fashion the marker on the fenestration with 5-0 stitch * If the fenestration is going to be made into a branch, then an appropriately sized, self-expanding stent is beveled and fashioned to be 15 mm long and sewn to the fenestration in addition to a snare with the 5-0 stitch * Two orientation markers are placed at the proximal edge and distal edge of the graft consisting of portions of the snare sewn to the anterior portion of the graft in a J fashion with a 5-0 stitch