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NCT04267055 · ClinicalTrials.gov registry record
DISSECT-N Post Market Data Collection Registry
A clinical trial of Thoracic Aortic Dissection, sponsored by Medtronic Cardiovascular.
- Completed
- Registry status
- 102
- Enrollment target
- 20
- Study locations
NCT04267055: Completed study of Thoracic Aortic Dissection, sponsored by Medtronic Cardiovascular.
NCT04267055 is a study of Thoracic Aortic Dissection that has completed, run by Medtronic Cardiovascular. The registered enrollment target is 102 participants, below the 760-participant average among 5 other Thoracic Aortic Dissection trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04267055, a study of Thoracic Aortic Dissection, has completed, sponsored by Medtronic Cardiovascular.
- COMPLETED
- Registry status
- 102 participants
- Enrollment target
- 20
- Study locations
Study Summary
DISSECT-N is a post-market registry designed to assess real-world safety and effectiveness of Valiant Navion Thoracic Stent Graft System in the treatment of thoracic aortic dissections in real world practice.
Primary Outcome
Safety: Major Adverse Events (MAEs) Defined as: all-cause mortality (ACM), retrograde type A dissection (RTAD), aortic rupture, permanent paraplegia and paraparesis, stent induced new entry tear, conversion to open repair, disabling stroke, and non-preexisting renal failure. Effectiveness: Technical success defined as ability to advance, deploy and position the Valiant Navion Thoracic Stent Graft at target site with successful coverage and sealing of the proximal entry tear and removal of the d
Conditions Studied
Interventions
- DEVICE Valiant Navion Thoracic Stent Graft System
Study Locations (20)
Other
- Rigshospitalet - Copenhagen
- General Hospital of Athens, Evaggelismos - Athens
- Ospedale San Raffaele - Milano - Milan
- Keio University Hospital - Tokyo
- St. Antonius Ziekenhuis - Nieuwegein
- Auckland City Hospital - Grafton
- Narodny Ustav Srdcovych a Cievnych Chorob, A.S. - Bratislava
New York
- Albany Medical Center - Albany
- Northwell Health Lenox Hill Hospital - New York
Pennsylvania
- UPMC Pinnacle Harrisburg Campus - Harrisburg
- Hospital of the University of Pennsylvania - Philadelphia
Alabama
- University of Alabama at Birmingham Hospital - Birmingham
Florida
- University of Florida Health Shands Hospital - Gainesville
Georgia
- Emory University Hospital - Atlanta
Michigan
- University of Michigan Health System - University Hospital - Ann Arbor
North Carolina
- Atrium Health's Carolinas Medical Center - Charlotte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2020-06-25 |
| Est. Completion | 2024-07-05 |
What the finished NCT04267055 record still lists
NCT04267055 is an observational study that tracks outcomes without assigning an intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 760-participant average among 5 other Thoracic Aortic Dissection trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Thoracic Aortic Dissection appearing as the primary indexed condition, and to 1 intervention - of which Valiant Navion Thoracic Stent Graft System is the first listed.
NCT04267055 names 20 study sites across 12 states, led by Other, New York, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04267055 about?
NCT04267055 is a clinical study titled "DISSECT-N Post Market Data Collection Registry". DISSECT-N is a post-market registry designed to assess real-world safety and effectiveness of Valiant Navion Thoracic Stent Graft System in the treatment of thoracic aortic dissections in real world practice.
What is the current status of trial NCT04267055?
This trial is currently completed. The enrollment target is 102 participants. The study started on 2020-06-25. Estimated completion is 2024-07-05.
What conditions does trial NCT04267055 study?
This clinical trial studies the following conditions: Thoracic Aortic Dissection.
What interventions are being tested in trial NCT04267055?
The interventions under investigation include: Valiant Navion Thoracic Stent Graft System (DEVICE).
Who is sponsoring clinical trial NCT04267055?
This trial is sponsored by Medtronic Cardiovascular, which has 44 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04267055 being conducted?
This trial has 20 study locations across Alabama, Florida, Georgia, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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