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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAndres Schanzer

About this trial

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.

Eligibility criteria

Qualifiers

Aortic or aortoiliac aneurysm with diameter ≥5.5 cm

Aortic or aortoiliac aneurysm with a history of growth ≥1.0 cm per year, or clinical indication for aneurysm repair based on symptoms

Cannot be treated with a currently available non-modified approved device

Symptomatic on presentation and unsafe to wait for the time necessary to obtain a currently available non-modified approved device

Disqualifiers

Exclusion Criteria Medical Exclusion Criteria

Cultural objection to receipt of blood or blood products

Allergy or sensitivity to stainless steel, polyester, polypropylene, solder (tin, silver), gold, or nitinol

Anaphylactic reaction to contrast that cannot be adequately pre-medicated

Trial design

Treatments tested in this trial

  • Custom Made Fenestrated or Branched Stent Graft

Treatment groups

600 Participants
are divided into 1 treatment group

Sponsors and collaborators

Andres Schanzer

Lead sponsor

University of Massachusetts, Worcester

Sponsor institution