DISSECT-N Post Market Data Collection Registry

Covidien

Status: Completed

Conditions: Thoracic Aortic Dissection

Treatments: Device: Valiant Navion Thoracic Stent Graft System

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04267055

MDT19030 DISSECT-N

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.