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
Sponsors and collaborators
Andres Schanzer
Lead sponsor
University of Massachusetts, Worcester
Sponsor institution