DISSECT-N Post Market Data Collection Registry

Completed

Conditions studied: Thoracic Aortic Dissection

In brief

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.

Key facts

Study ID

NCT04267055

Run by

Medtronic Cardiovascular

People needed

102

Starts

2020-06-25

Expected to finish

2024-07-05

Last updated by the study team

2025-07-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is ≥18 years old
• 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

You may not qualify if…

• Subject is participating in an investigational drug or device study which may bias or interfere with the endpoints and follow-up of this study.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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