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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 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. The trial reports 2 study locations across 1 state.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03075748
The ClinicalTrials.gov registry entry for NCT03075748 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of South Florida, which has 252 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 1 distinct geographic area - top geographies include 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.
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