NCT04524247 Frailty and Physician Modified Fenestrated Endograft for Thoracoabdominal Aortic Pathologies
| NCT ID | NCT04524247 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Southern California |
| Condition | Thoracoabdominal Aortic Aneurysm |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-02-23 |
| Primary Completion | 2028-07-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2021-02-23 with a primary completion date of 2028-07-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
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 ≥ 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.
Contact & Investigator
Sukgu M Han, MD, MS
PRINCIPAL INVESTIGATOR
University of Southern California
Frequently Asked Questions
Who can join the NCT04524247 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Thoracoabdominal Aortic Aneurysm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04524247 currently recruiting?
Yes, NCT04524247 is actively recruiting participants. Contact the research team at Kathleen.O'Donnell@med.usc.edu for enrollment information.
Where is the NCT04524247 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT04524247 clinical trial?
NCT04524247 is sponsored by University of Southern California. The principal investigator is Sukgu M Han, MD, MS at University of Southern California. The trial plans to enroll 100 participants.