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โ† Trials
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Frailty and Physician Modified Fenestrated Endograft for Thoracoabdominal Aortic Pathologies

RecruitingNAAges 18 Years - anyAllUniversity of Southern California
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In plain words

What the trial is, and whether it could suit you

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 b

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Patients may be included in the study if the patient has at least one of the following indications and are anatomically appropriate for treatment with fenestrated/branched stent grafts. 1. Pararenal, paravisceral, and type I to IV thoracoabdominal aortic aneurysms or chronic post-dissection aneurysms with a diameter 5cm or 2 times the normal aortic diameter. 2. Aneurysm with a history of growth โ‰ฅ 0.5cm per year. 3. Saccular aneurysms deemed at significant risk for rupture based on physician interpretation. 4. Symptomatic aneurysm without hemodynamic instability 5. Aneurysms meeting any of the above criteria 1\~4, above or below the previous endovascular and/or open aortic repairs. Previously placed aortic stent graft or open aortic grafts may serve as seal zones. Exclusion Criteria: * Patients must be excluded from the study if any of the following conditions is true: 1. Less than 18 years of age. 2. Unwilling to comply with the follow-up schedule. 3. Inability or refusal to give informed consent by the patient or a legally authorized representative. 4. Pregnant or breastfeeding. 5. Life-expectancy less than 2 years. 6. Participation in another investigational clinical or device trial, with the exception of participation in another investigational endovascular stent-graft protocol and performed remotely from the fenestrated procedure (\>30 days). Examples include remote (\>30days) participation in a thoracic, or abdominal branch device trial. 7. Eligible for treatment with FDA-approved marketed device. 8. Eligible and willing to travel to a center with IDE protocol wherein the device is made by a manufacturer.
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What it tests

  • Physician Modified Endografts
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Where

1 site
Keck Hospital of University of Southern California
Los Angeles, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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