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NCT05339061 · ClinicalTrials.gov registry record · NA
Physician Modified Endograft For Complex Aortic Aneurysm Repair
A NA study of Thoracoabdominal Aortic Aneurysm and Juxtarenal Aortic Aneurysm, sponsored by University of California, Davis.
- Recruiting
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT05339061 is a NA study of Thoracoabdominal Aortic Aneurysm and Juxtarenal Aortic Aneurysm that is actively recruiting participants, run by University of California, Davis. The registered enrollment target is 40 participants, below the 197-participant average among 11 other Thoracoabdominal Aortic Aneurysm trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05339061, a NA study of Thoracoabdominal Aortic Aneurysm and Juxtarenal Aortic Aneurysm, is actively recruiting participants, sponsored by University of California, Davis.
- RECRUITING
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
The physician modified endograft is intended for treating complex, pararenal, juxtarenal and thoracoabdominal aortic aneurysms requiring coverage of renal arteries, the superior mesenteric artery or the celiac trunk in high-risk patients who do not have an option for endovascular repair with an FDA approved endograft and have an appropriate anatomy. There will be one investigational site with a total of 40 subjects to be enrolled. Time to complete enrollment will be 24 months and the subject follow-up time will be five years from last subject enrollment. The primary safety endpoint is freedom from major adverse events (MAE) at 30 days or during hospitalization if this exceeds 30 days. The primary effectiveness endpoint is the proportion of study subjects with treatment success at one year. The subjects will be followed at one month, six months, one year, and yearly thereafter for a total period of five years. Subjects will be followed up clinically for life. Clinical exam follow up may be phone or video visit with CT scan evaluation and duplex ultrasound as needed. The proportion of treatment group subjects that achieve and maintain treatment success annually to five years will be investigated.
Conditions Studied
Interventions
- DEVICE Endovascular Treatment of Complex abdominal or Thorocoabdominal aneurysms (TAAA).
Study Locations (1)
California
- University of California San Diego - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2023-03-01 |
| Est. Completion | 2029-12 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05339061
The ClinicalTrials.gov registry entry for NCT05339061 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 197-participant average among 11 other Thoracoabdominal Aortic Aneurysm trials with a reported enrollment target (80% lower). The listed sponsor is University of California, Davis, which has 657 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 Endovascular Treatment of Complex abdominal or Thorocoabdominal aneurysms (TAAA). is the first listed.
NCT05339061 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT05339061 about?
NCT05339061 is a clinical study titled "Physician Modified Endograft For Complex Aortic Aneurysm Repair". The physician modified endograft is intended for treating complex, pararenal, juxtarenal and thoracoabdominal aortic aneurysms requiring coverage of renal arteries, the superior mesenteric artery or the celiac trunk in high-risk patients who do not have an option for endovascular repair with an FDA ...
What is the current status of trial NCT05339061?
This trial is currently recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2023-03-01. Estimated completion is 2029-12.
What conditions does trial NCT05339061 study?
This clinical trial studies the following conditions: Thoracoabdominal Aortic Aneurysm, Juxtarenal Aortic Aneurysm, Pararenal Aortic Aneurysm, Complex Abdominal Aortic Aneurysm.
What interventions are being tested in trial NCT05339061?
The interventions under investigation include: Endovascular Treatment of Complex abdominal or Thorocoabdominal aneurysms (TAAA). (DEVICE).
Who is sponsoring clinical trial NCT05339061?
This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05339061 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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