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NCT02365467 · ClinicalTrials.gov registry record
Evaluation of the Valiant Mona LSA Thoracic Stent Graft System in Descending TAA and Chronic Dissections
A clinical trial, sponsored by Medtronic Cardiovascular.
- Completed
- Registry status
- 32
- Enrollment target
NCT02365467: Completed study, sponsored by Medtronic Cardiovascular.
NCT02365467 is a clinical trial that has completed, run by Medtronic Cardiovascular. The registered enrollment target is 32 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02365467 has completed, sponsored by Medtronic Cardiovascular.
- COMPLETED
- Registry status
- 32 participants
- Enrollment target
Study Summary
The purpose of the Feasibility study is to characterize the safety of the Valiant Mona LSA Thoracic Stent Graft System, including an assessment of the safety and effectiveness of the device acutely and at the 30 day visit in the identified subject population. This study will also evaluate the current instructions for use and may direct changes to the delivery and deployment steps. The purpose of the expansion to the Feasibility Study is to characterize the Valiant Mona LSA Thoracic Stent Graft System, in particular to assess the safety and effectiveness of the device acutely and at the 30 day visit, in subjects enrolled with chronic, Type B dissections.
Primary Outcome
Within 1 month (Day 0 - Day 30) from the index procedure, composite endpoint consisting of: * Aorta Related Mortality * Stroke * Paraplegia * Left Arm/Hand Ischemia
Interventions
- DEVICE Valiant Mona LSA Thoracic Stent Graft System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2015-04-16 |
| Est. Completion | 2024-12-05 |
What the finished NCT02365467 record still lists
NCT02365467 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Valiant Mona LSA Thoracic Stent Graft System is the first listed.
NCT02365467 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02365467 about?
NCT02365467 is a clinical study titled "Evaluation of the Valiant Mona LSA Thoracic Stent Graft System in Descending TAA and Chronic Dissections". The purpose of the Feasibility study is to characterize the safety of the Valiant Mona LSA Thoracic Stent Graft System, including an assessment of the safety and effectiveness of the device acutely and at the 30 day visit in the identified subject population. This study will also evaluate the curren...
What is the current status of trial NCT02365467?
This trial is currently completed. The enrollment target is 32 participants. The study started on 2015-04-16. Estimated completion is 2024-12-05.
What interventions are being tested in trial NCT02365467?
The interventions under investigation include: Valiant Mona LSA Thoracic Stent Graft System (DEVICE).
Who is sponsoring clinical trial NCT02365467?
This trial is sponsored by Medtronic Cardiovascular, which has 44 total clinical trials registered on ClinicalTrials.gov.
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