Frailty and Physician Modified Fenestrated Endograft for Thoracoabdominal Aortic Pathologies
Impact of Frailty on Clinical Outcomes of Patients Treated for Thoracoabdominal and Complex Abdominal Aortic Aneurysms With Physician-Modified Fenestrated and Branched Stent Grafts
University of Southern California
100 participants
Feb 23, 2021
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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 Criteria9
- 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.
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Interventions
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)
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NCT04524247