Endovascular Repair for Aortic Aneurysm

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Texas Southwestern Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial tests special medical devices, either custom-made or pre-made, to fix weakened areas in the main blood vessel (aorta) in patients with specific types of aortic aneurysms. These devices support the weakened sections to prevent them from rupturing. The Zenith platform has been used in various studies for treating complex aortic aneurysms.

Eligibility Criteria

This trial is for adults with specific types of aortic aneurysms (bulges in the wall of the artery) that are at risk of rupture and not suitable for standard treatment. Candidates must have anatomy compatible with custom-made or off-the-shelf stent-grafts, be able to follow up, and consent to participate. Pregnant individuals, those with recent procedures or participation in other trials, severe allergies to contrast material, certain infections or connective tissue disorders are excluded.

Inclusion Criteria

I cannot or will not give my consent to participate.

I have a blood clotting disorder that cannot be corrected.

Pregnant, breast-feeding, or planning on becoming pregnant within 60 months

+25 more

Exclusion Criteria

My aortic dissection does not meet the specific trial criteria.

My aortic arch condition does not meet the specific criteria mentioned.

Participant Groups

The study tests endovascular repair devices on three groups: one using custom devices for juxtarenal/suprarenal/type IV thoracoabdominal aneurysms; another for type I-III thoracoabdominal aneurysms needing branched/fenestrated devices; and a third group treated with patient-specific stent-grafts for aortic arch aneurysms.

3Treatment groups

Experimental Treatment

Group I: Type I - III TAAA cohortExperimental Treatment1 Intervention

Patients enrolled in this arm will be implanted with the custom made/ off-the-shelfp branched devices. The device is aimed to treat type I-III TAAAs.

Group II: Fenestrated CMD cohortExperimental Treatment1 Intervention

Patients enrolled in this arm will be implanted with the custom made fenestrated device. The device is aimed to treat complex abdominal aortic aneurysms including juxtarenal, suprarenal and type IV thoracoabdominal aneurysms.

Group III: Arch cohortExperimental Treatment1 Intervention

Patients enrolled in this arm will be implanted with patient-specific stent-grafts with one to three inner branches or a scallop.