To determine the safety and feasibility of the investigational product to reduce aortic dissection false lumen perfusion.
≥18 years of age.
A candidate for false lumen (FL) embolization with a type B dissection, and no prior primary entry tear/TL treatment, OR
A candidate for FL embolization with a type B or type A dissection, in whom the primary entry tear/TL was treated in a previous procedure, and is now presenting with a FL requiring treatment.
An inability to provide informed consent.
Enrolled in another clinical study other than a registry.
Hyperacute or acute aortic dissection (<15 days from symptom onset).
Untreated or uncovered primary entry/reentry tear proximal to left subclavian artery (before FL treatment with the investigational product).
Single group
False Lumen Embolization System, IMPEDE-FX RapidFill
DeviceEmbolization of the false lumen of an aortic dissection
Technical success
Delivery and implantation of the investigational product implant to the false lumen
Major adverse events
Incidence of device/procedure-related major adverse events
All-cause mortality and dissection-related mortality
Incidence of all-cause mortality and dissection-related mortality
Serious adverse events
Incidence of device/procedure-related serious adverse events
Change in false lumen thrombosis from baseline
Change in false lumen thrombosis from baseline
Change in true lumen/aorta size ratio from baseline
Change in true lumen/aorta size ratio from baseline
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