DISSECT-N (Dissection Navion Registry)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 200
- Locations
- 22
- Primary Endpoint
- Composite safety and effectiveness
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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-
- •Relevant history of COVID-19 is defined as availability of a positive COVID-19 test with sequela or hospitalization for treatment of COVID-
- •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.
Outcomes
Primary Outcomes
Composite safety and effectiveness
Time Frame: 1-month post index procedure
Safety: Major Adverse Events (MAEs) Defined as: all-cause mortality (ACM), retrograde type A dissection (RTAD), aortic rupture, permanent paraplegia and paraparesis, stent induced new entry tear, conversion to open repair, disabling stroke, and non-preexisting renal failure. Effectiveness: Technical success defined as ability to advance, deploy and position the Valiant Navion Thoracic Stent Graft at target site with successful coverage and sealing of the proximal entry tear and removal of the delivery system. The primary endpoint is a dichotomous study outcome and a composite endpoint. A subject who has technical success and no MAE reported within 1-month will be considered a success.
Secondary Outcomes
- Aortic remodeling(1-month, 1, 2 and 3 years)
- Endoleaks(1-month, 1, 2 and 3 years)
- Stent induced entry tear(1, 2 and 3 years)
- Stent graft migration(1, 2 and 3 years)
- Transient Ischemic Attack (TIA)/minor strokes(1-month)
- Access related complications(peri-operative)
- Unplanned secondary procedures(1, 2 and 3 years)
- False lumen perfusion(1-month, 1, 2 and 3 years)
- Disease progression(1,2 and 3 years)
- Transient spinal cord ischemia(1-month, 1, 2 and 3 years)
- Major adverse events(1, 2 and 3 years)
- Stent graft integrity(1-month, 1, 2 and 3 years)