Clinical Outcomes and Quality of Life Measures in Patients Treated for Complex Abdominal Aortic Aneurysms With Fenestrated Stent Grafts
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The purpose of this study is to evaluate clinical outcomes and quality of life measures in treated by endovascular aortic repair of juxtarenal, suprarenal, and type IV thoracoabdominal aortic aneurysms using custom-made Cook Zenith® Fenestrated AAA Endovascular Graft.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• A patient may be included in the study if the patient has at least one of the following and is appropriate for treatment with a custom-made Zenith® Fenestrated AAA Endovascular Graft:
• Juxtarenal, suprarenal or type IV thoracoabdominal aortic aneurysm with a diameter ≥ 5.0 cm or 2 times the normal aortic diameter
• Aneurysm with a history of growth ≥ 0.5 cm per year
• Saccular aneurysms deemed at significant risk for rupture based upon physician interpretation.
Locations
United States
Minnesota
Mayo Clinic
ACTIVE_NOT_RECRUITING
Rochester
Texas
The University of Texas Health Science Center at Houston
RECRUITING
Houston
Contact Information
Primary
Safa Savadi Osgouei, MD
Safa.savadiosgouei@uth.tmc.edu
(713) 486-5361
Time Frame
Start Date: 2013-08
Estimated Completion Date: 2030-05
Participants
Target number of participants: 200
Treatments
Other: Endovascular
The study will include patients treated by endovascular aortic repair of juxtarenal, suprarenal and type IV thoracoabdominal aortic aneurysms using custom-made Cook Zenith® Fenestrated AAA Endovascular Graft. The graft includes combinations of scallops, holes (fenestrations) or cuffs (side branches) . These small holes or branches are the investigational part of this research study. The arteries to the liver, intestine, and kidneys will be have a stent (small tubular stainless steel structures) to help keep the arteries open and aligned with the fenestrations or branches.~Other names:~Endovascular stent Stent-graft
Authors
Related Therapeutic Areas
Sponsors
Collaborators: Cook Group Incorporated
Leads: Gustavo Oderich