Actively Recruiting
Frailty and Physician Modified Fenestrated Endograft for Thoracoabdominal Aortic Pathologies
Led by University of Southern California · Updated on 2024-07-01
100
Participants Needed
1
Research Sites
592 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Frailty and Physician Modified Fenestrated Endograft for Thoracoabdominal Aortic Pathologies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has a thoracoabdominal or pararenal aortic aneurysm or chronic post-dissection aneurysm with diameter 5cm or twice the normal aortic diameter
- Aneurysm has grown 0.5cm or more per year
- Saccular aneurysm considered at high risk for rupture by a physician
- Symptomatic aneurysm without hemodynamic instability
- Aneurysm meets above criteria regardless of previous endovascular or open aortic repairs
- Patient has anatomy suitable for fenestrated or branched stent graft treatment
You will not qualify if you...
- Younger than 18 years old
- Unwilling to follow the study visit schedule
- Unable or unwilling to give informed consent
- Pregnant or breastfeeding
- Life expectancy less than 2 years
- Participating in another investigational clinical or device trial within 30 days, except certain remote endovascular trials
- Eligible for treatment with an FDA-approved marketed device
- Eligible and willing to travel to a center using an IDE protocol device made by a manufacturer
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Keck Hospital of University of Southern California
Los Angeles, California, United States, 90033
Actively Recruiting
Research Team
K
Katie O'Donnell, MPH
CONTACT
J
Jacquelyn Paige, MSN, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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