Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
102 participants
OBSERVATIONAL
2020-06-25
2024-07-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Valiant Navion Thoracic Stent Graft System
Placement of the Valiant Navion for endovascular repair of a dissection in the thoracic aorta.
Eligibility Criteria
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Inclusion Criteria
* Subject was treated in the last 7 days, or is intended to be treated, with the Valiant Navion Thoracic Stent Graft System for a dissection in the thoracic aorta
* Subject is willing to comply with standard of care clinical follow-up
* Subject or legal representative or consultee, as applicable has consented for study participation and signed the approved Informed Consent
Exclusion Criteria
* Subject is pregnant (not an exclusion if allowed per local regulatory requirements, pregnancy test to be performed where required)
* Subject has an active COVID-19 infection or relevant history of COVID-19. Relevant history of COVID-19 is defined as availability of a positive COVID-19 test with sequela or hospitalization for treatment of COVID-19. Subjects with a positive COVID-19 test who were asymptomatic or had mild symptoms should be excluded only if the positive test was less than 3 months prior to enrollment.
18 Years
ALL
No
Sponsors
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NAMSA
OTHER
Medtronic Cardiovascular
INDUSTRY
Responsible Party
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Principal Investigators
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Ross Milner, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Chicago Medicine & Biological Sciences
Locations
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University of Alabama at Birmingham Hospital
Birmingham, Alabama, United States
University of Florida Health Shands Hospital
Gainesville, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
University of Michigan Health System - University Hospital
Ann Arbor, Michigan, United States
Albany Medical Center
Albany, New York, United States
Northwell Health Lenox Hill Hospital
New York, New York, United States
Atrium Health's Carolinas Medical Center
Charlotte, North Carolina, United States
UPMC Pinnacle Harrisburg Campus
Harrisburg, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Baylor Plano
Plano, Texas, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Rigshospitalet
Copenhagen, , Denmark
General Hospital of Athens, Evaggelismos
Athens, , Greece
Ospedale San Raffaele - Milano
Milan, , Italy
National Cerebral and Cardiovascular Center
Suita, Osaka, Japan
Keio University Hospital
Tokyo, , Japan
St. Antonius Ziekenhuis
Nieuwegein, , Netherlands
Auckland City Hospital
Grafton, , New Zealand
Narodny Ustav Srdcovych a Cievnych Chorob, A.S.
Bratislava, , Slovakia
Severance Hospital
Seoul, , South Korea
Songklanagarind Hospital
Hat Yai, Changwat Songkhla, Thailand
Countries
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Other Identifiers
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MDT19030 DISSECT-N
Identifier Type: -
Identifier Source: org_study_id
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