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NCT04524247 · ClinicalTrials.gov registry record · NA
Frailty and Physician Modified Fenestrated Endograft for Thoracoabdominal Aortic Pathologies
A NA study of Thoracoabdominal Aortic Aneurysm and Frailty Syndrome, sponsored by University of Southern California.
- Recruiting
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT04524247 is a NA study of Thoracoabdominal Aortic Aneurysm and Frailty Syndrome that is actively recruiting participants, run by University of Southern California. The registered enrollment target is 100 participants, below the 191-participant average among 11 other Thoracoabdominal Aortic Aneurysm trials with a reported enrollment target (48% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04524247, a NA study of Thoracoabdominal Aortic Aneurysm and Frailty Syndrome, is actively recruiting participants, sponsored by University of Southern California.
- RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DEVICE Physician Modified Endografts
Study Locations (1)
California
- Keck Hospital of University of Southern California - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2021-02-23 |
| Est. Completion | 2032-07-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04524247
The ClinicalTrials.gov registry entry for NCT04524247 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 191-participant average among 11 other Thoracoabdominal Aortic Aneurysm trials with a reported enrollment target (48% lower). The listed sponsor is University of Southern California, which has 617 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Thoracoabdominal Aortic Aneurysm appearing as the primary indexed condition, and to 1 intervention - of which Physician Modified Endografts is the first listed.
NCT04524247 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT04524247 about?
NCT04524247 is a clinical study titled "Frailty and Physician Modified Fenestrated Endograft for Thoracoabdominal Aortic Pathologies". 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-modifie...
What is the current status of trial NCT04524247?
This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2021-02-23. Estimated completion is 2032-07-02.
What conditions does trial NCT04524247 study?
This clinical trial studies the following conditions: Thoracoabdominal Aortic Aneurysm, Frailty Syndrome, Pararenal Aneurysm, Thoracoabdominal; Aortic, Aneurysm, Dissecting.
What interventions are being tested in trial NCT04524247?
The interventions under investigation include: Physician Modified Endografts (DEVICE).
Who is sponsoring clinical trial NCT04524247?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04524247 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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