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NCT03075748 · ClinicalTrials.gov registry record · NA
Visceral Manifold Study for the Repair of TAAA
A NA study of Thoracoabdominal Aortic Aneurysms, sponsored by University of South Florida.
- Active
- Registry status
- NA
- Development phase
- 15
- Enrollment target
- 2
- Study locations
NCT03075748: Active NA study of Thoracoabdominal Aortic Aneurysms, sponsored by University of South Florida.
NCT03075748 is a NA study of Thoracoabdominal Aortic Aneurysms that is active but no longer recruiting, run by University of South Florida. The registered enrollment target is 15 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03075748, a NA study of Thoracoabdominal Aortic Aneurysms, is active but no longer recruiting, sponsored by University of South Florida.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
- 2
- Study locations
Study Summary
The outcomes from prior clinical evaluation of the study device, including successfully treating 99% (84/85) of the intended target vessels and 96% (27/28) limb patency observed at one year, demonstrate the potential benefits of the device. When contrasted with open repair's significant complication rates and branch fenestrated device's significant anatomic and logistic limitations, the potential risk of the proposed novel graft does not outweigh the potential benefit of widened anatomic availability and improved patency rates. Given the potential benefits, the investigators feel that it is justified to expose the target patient population to the potential risk. The non-clinical testing performed by Medtronic and the clinical results reported by Sanford Health show adequate safety of the device to support an early feasibility study. The investigators would like to perform an early feasibility study under a defined and controlled protocol to collect prospective preliminary safety and device functionality data. The investigators believe an early feasibility study is most appropriate for this novel approach. The limited sample size allows adequate patient data to be collected under a controlled protocol without exposing a large patient population to the risk associated with a novel device design.
Primary Outcome
Primary safety outcome: Major adverse events include death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke
Conditions Studied
Interventions
- DEVICE TAAA Debranching Stent Graft System
Study Locations (2)
Florida
- Tampa General Hospital/ University of South Florida - Tampa
- University of South Florida - South Tampa Campus - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2017-12-19 |
| Est. Completion | 2027-02-01 |
| Phase | NA |
What the registry record for NCT03075748 still lists
NCT03075748 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Thoracoabdominal Aortic Aneurysms appearing as the primary indexed condition, and to 1 intervention - of which TAAA Debranching Stent Graft System is the first listed.
NCT03075748 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT03075748 about?
NCT03075748 is a clinical study titled "Visceral Manifold Study for the Repair of TAAA". The outcomes from prior clinical evaluation of the study device, including successfully treating 99% (84/85) of the intended target vessels and 96% (27/28) limb patency observed at one year, demonstrate the potential benefits of the device. When contrasted with open repair's significant complication...
What is the current status of trial NCT03075748?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 15 participants. The study started on 2017-12-19. Estimated completion is 2027-02-01.
What conditions does trial NCT03075748 study?
This clinical trial studies the following conditions: Thoracoabdominal Aortic Aneurysms.
What interventions are being tested in trial NCT03075748?
The interventions under investigation include: TAAA Debranching Stent Graft System (DEVICE).
Who is sponsoring clinical trial NCT03075748?
This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03075748 being conducted?
This trial has 2 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03075748's enrollment target sits among peer trials
15 1881st of 2000 higher than 92 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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