Custom-modified stent grafts for aortic aneurysms, and the role of frailty
Tests physician-modified stent grafts for complex aortic aneurysms, looking at patient frailty.
Key facts
- Who runs it
- University of Southern California
- Where
- Los Angeles, United StatesSee the site
- Trial code
- Registry title
- Frailty and Physician Modified Fenestrated Endograft for Thoracoabdominal Aortic Pathologies
- Status
- Recruiting
- People taking part
- 100 people, planned
- Started
- 23 Feb 2021
- Expected to end
- 2 Jul 2032
- Type of study
- Interventional
- Treatments tested
- Physician Modified Endografts
- Record updated
- 1 July 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a thoracoabdominal or complex abdominal aortic aneurysm (a bulge in the main body artery) who face high risk from open surgery. They must have an artery shape that allows repair with a physician-modified fenestrated or branched stent graft.
- Age
- 18 years and older
- Sex
- All sexes
- Disease stage
- Pararenal, paravisceral or type I to IV thoracoabdominal aneurysm, or chronic aneurysm after a tear in the artery wall, with a diameter of 5cm (2 in) or 2 times the normal artery size. Other ways in: growth of ≥ 0.5cm per year, a saccular aneurysm at significant risk of bursting, or an aneurysm causing symptoms without unstable blood pressure or circulation.
- Earlier treatment
- Earlier stent graft or open repair of the aorta is allowed. The aneurysm may be above or below the earlier repair.
Main reasons for not taking part
- Pregnant or breastfeeding
- Expected to live less than 2 years
- Can be treated with an FDA-approved device on the market
- Able and willing to travel to a center offering a manufacturer-made device under a study protocol
- In another investigational trial, except a stent-graft trial done more than 30 days apart
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in United States
- Keck Hospital of University of Southern CaliforniaLos Angeles, United StatesContact: Marie GrimesTaking people
About the trial
What the trial wants to find out
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).
Read full original descriptionShow less
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.
The group in the trial
- PMEG FEVARTreatment being tested
The only arm of this study will be enrolled subjects who undergo physician modified endografting as a treatment of their thoracoabdominal aortic aneurysms or complex abdominal aortic aneurysms.
Treatment: Physician Modified Endografts
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Impact of Frailty on Clinical Outcomes of Patients Treated for Thoracoabdominal and Complex Abdominal Aortic Aneurysms With Physician-Modified Fenestrated and Branched Stent Grafts
- Plain-language title
- Custom-modified stent grafts for aortic aneurysms, and the role of frailtyGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 1 July 2024