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.
- Thoracic Aortic Dissection
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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
- 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.
- Study Type
- Observational [Patient Registry]
- Observational Model
- Time Perspective
- Medtronic Endovascular
DISSECT-N is a prospective, observational, global, multi-center, 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.