Modified Stent Grafts for Aortic Aneurysm
(Assets Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Jesse Manunga, MD

No Placebo Group

Trial Summary

What is the purpose of this trial?

The primary objective of the present study is to evaluate the safety, effectiveness, and clinical outcomes of surgeon-modified fenestrated stent grafts used to treat patients with failed previous infrarenal repairs (failed EVAR) and complex aortic aneurysms (thoracoabdominal, juxtarenal, pararenal, and paravisceral aneurysms).

Eligibility Criteria

This trial is for adults with complex aortic aneurysms or failed previous infrarenal repairs, who are at high risk for open surgery. Candidates must have certain aneurysm sizes or symptoms and suitable anatomy for the procedure. Pregnant women, those under 18, patients with allergies to device materials, uncorrectable coagulopathy, or severe kidney issues cannot participate.

Inclusion Criteria

You have an aneurysm that is larger than a specific size, has grown quickly, is causing symptoms, has ruptured, or has not responded well to previous treatment.

My blood vessels are suitable for surgery, and I have a specific type of aortic condition.

Your overall health status is classified as low, medium, or high risk according to specific assessment systems.

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Exclusion Criteria

Unwilling or unable to comply with the follow-up schedule

I cannot or do not want to give consent for the trial.

I see several exclusion criteria for the medical study: - You are allergic to the materials used in the devices. - You are allergic to anticoagulation or contrast media. - You have a blood clotting problem that cannot be corrected. - Your body shape makes it hard to see your aorta using x-rays. - You had major surgery or a procedure not related to treating the planned aneurysm within the last 30 days. - You have unstable angina (chest pain). - You have an infection that could increase the risk of endovascular graft infection. - Your baseline creatinine level is higher than 2.0 mg/dL. - You have a history of certain connective tissue disorders, except if you've had a previous open surgical aortic replacement.

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Treatment Details

Interventions

Surgeon-Modified fenestrated stent grafts using Cook Zenith Platform (Zfen, TX2, Alpha Thoracic Endovascular Graft and Zenith Flex) (Stent Graft)

Trial OverviewThe trial tests surgeon-modified fenestrated stent grafts on patients with complex aortic aneurysms or prior unsuccessful endovascular repairs. It aims to assess safety and effectiveness of these custom-made devices in managing life-threatening aortic conditions.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Thoracoabdominal aortic aneurysm extent I-IIIExperimental Treatment1 Intervention

Thoracoabdominal aortic aneurysm extent I-III (proximal seal can be from the left carotid artery to directly after the left subclavian artery):

Group II: Failed EVARExperimental Treatment1 Intervention

Failed EVAR (defined as type IA endoleak or increase in aneurysm sac size in the setting of proximal seal loss)/juxtarenal/Pararenal/paravisceral/thoracoabdominal aortic aneurysm extent IV-V: