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Frailty and Physician Modified Fenestrated Endograft for Thoracoabdominal Aortic Pathologies
Sponsor: University of Southern California
Summary
The primary objective of this single arm, prospective feasibility study, Impact of Frailty on Clinical Outcomes of Patients Treated for Thoracoabdominal and Complex Abdominal Aortic Aneurysms with Physician-Modified Fenestrated and Branched Stent Grafts, is to assess the use of the physician-modified fenestrated/branched endografts to repair thoracoabdominal and complex aortic aneurysms in subjects having appropriate anatomy, at high risks for open repairs. The primary intent of the study is to assess safety and preliminary effectiveness of the device acutely (i.e., treatment success and technical success), at 30 days (i.e., the rate of major adverse events (MAE)) and at 3 months, 6 months, 12 months, and annually to 5 years (i.e., the proportion of treatment group subjects that achieve and maintain treatment success). Additionally, this study will assess the degree of patient frailty before and after the aneurysm repair, as well as the association between the preoperative baseline frailty and clinical outcomes detailed above. This will help improve subject selection in identification of high risk patients who would not only suffer poor clinical outcomes, but also experience decline in their functional status.
Official title: Impact of Frailty on Clinical Outcomes of Patients Treated for Thoracoabdominal and Complex Abdominal Aortic Aneurysms With Physician-Modified Fenestrated and Branched Stent Grafts
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2021-02-23
Completion Date
2032-07-02
Last Updated
2024-07-01
Healthy Volunteers
No
Conditions
Interventions
Physician Modified Endografts
Modification procedure Description of modified device is detailed in Section 3.5 of IDE. In summary, the steps involved in modification of the Zenith Alpha thoracic stent grafts are; 1. Unsheathing of the stent graft 2. Retrieval of a trigger wire from the inner cannula of the delivery system 3. Rerouting of the trigger wire along the stent graft 4. Removal of proximal barbs. 5. Creation of fenestrations and/or branch cuffs 6. Placement of radiopaque markers around the fenestrations/ branch cuffs 7. Placement of temporary and/or permanent diameter constraining ties 8. (Optional) Placement of preloaded wires through the fenestrations/branch cuffs
Locations (1)
Keck Hospital of University of Southern California
Los Angeles, California, United States