Thoracic Aortic Dissection
Conditions
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.
Interventions
DEVICEValiant Navion Thoracic Stent Graft System
Placement of the Valiant Navion for endovascular repair of a dissection in the thoracic aorta.
Sponsors
NAMSA
Medtronic Cardiovascular
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite safety and effectiveness | 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
| Measure | Time frame | Description |
|---|---|---|
| Aortic remodeling | 1-month, 1, 2 and 3 years | Rate of aortic remodeling based on follow-up imaging. |
| Access related complications | peri-operative | Rate of access related complications as proportion of evaluable patients. |
| Stent induced entry tear | 1, 2 and 3 years | Rate of stent induced entry tear as proportion of evaluable patients. |
| Stent graft migration | 1, 2 and 3 years | Rate of stent graft migration (\>10mm) as proportion of evaluable patients. |
| Stent graft integrity | 1-month, 1, 2 and 3 years | Rate of each type of loss of stent graft integrity (kink, twist, fracture, occlusion, or stenosis) as a proportion of evaluable patients based on follow-up imaging. |
| Disease progression | 1,2 and 3 years | Extension of dissection. |
| Transient Ischemic Attack (TIA)/minor strokes | 1-month | Rate of TIA/minor stroke as a proportion of evaluable patients. |
| Transient spinal cord ischemia | 1-month, 1, 2 and 3 years | Rate of transient spinal cord ischemia as a proportion of evaluable patients. |
| Unplanned secondary procedures | 1, 2 and 3 years | Rate of unplanned secondary procedures. |
| False lumen perfusion | 1-month, 1, 2 and 3 years | Rate of each type of false lumen perfusion based on follow-up imaging. |
| Endoleaks | 1-month, 1, 2 and 3 years | Rate of each type of endoleak based on follow-up imaging. |
| Major adverse events | 1, 2 and 3 years | Major adverse events defined as: * All-cause mortality (ACM) * Retrograde type A dissection (RTAD) * Aortic rupture * Permanent paraplegia and paraparesis * Stent induced new entry tear * Conversation to open repair * Disabling stroke * Non-preexisting renal failure |
Countries
Denmark, Greece, Italy, Japan, Netherlands, New Zealand, Slovakia, South Korea, Thailand, United States
Outcome results
None listed