Clinical trials

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Condition / disease
Location
Status: Recruiting

Complex Aortic Aneurysm Repair Using Physician Modified Endografts and Custom Made Devices

The purpose of this study is to evaluate the safety and efficacy of custom made devices, Zenith t-Branch devices and physician modification of FDA approved off-the-shelf endovascular grafts in the treatment of patients with complex abdominal aneurysms, aortoiliac aneurysms, thoracoabdominal aneurysms and aortic arch aneurysms who (1) have anatomy not suitable for endovascular repair using grafts currently marketed in the United States,(2) are deemed unsafe to wait the required time necessary for commercial endograft manufacturing, and (3) are at high risk for open surgical repair. Amendment to the study has created a cohort open to people with connective tissue diseases such as Marfan, Ehlers-Danlos or Loey-Dietz syndromes to enroll in the trial. An additional amendment to the study allows the use of a custom made device to treat an aneurysm in the aortic arch.

Participants needed: 600
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Andres SchanzerUpdated: Oct 22, 2025Locations: 1
Eligibility criteria

Aortic or aortoiliac aneurysm with diameter ≥5.5 cm [+8]

Exclusion Criteria Medical Exclusion Criteria [+21]