Status:
RECRUITING
Frailty and Physician Modified Fenestrated Endograft for Thoracoabdominal Aortic Pathologies
Lead Sponsor:
University of Southern California
Conditions:
Thoracoabdominal Aortic Aneurysm
Thoracoabdominal; Aortic, Aneurysm, Dissecting
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 Phy...
Detailed Description
Device Description Two types of commercially approved thoracic aortic stent-grafts will be modified under the aegis of a physician-sponsored IDE protocol (G200159). The Cook (Bloomington, IN) Zenith ...
Eligibility Criteria
Inclusion
- 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.
- 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.
- Aneurysm with a history of growth ≥ 0.5cm per year.
- Saccular aneurysms deemed at significant risk for rupture based on physician interpretation.
- Symptomatic aneurysm without hemodynamic instability
- 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
- Patients must be excluded from the study if any of the following conditions is true:
- Less than 18 years of age.
- Unwilling to comply with the follow-up schedule.
- Inability or refusal to give informed consent by the patient or a legally authorized representative.
- Pregnant or breastfeeding.
- Life-expectancy less than 2 years.
- 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.
- Eligible for treatment with FDA-approved marketed device.
- Eligible and willing to travel to a center with IDE protocol wherein the device is made by a manufacturer.
Key Trial Info
Start Date :
February 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 2 2032
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04524247
Start Date
February 23 2021
End Date
July 2 2032
Last Update
July 1 2024
Active Locations (1)
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1
Keck Hospital of University of Southern California
Los Angeles, California, United States, 90033