DISSECT-N Post Market Data Collection Registry (NCT04267055) | Clinical Trial Compass
CompletedNot Applicable
DISSECT-N Post Market Data Collection Registry
United States102 participantsStarted 2020-06-25
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.