About this trial
To determine the safety and feasibility of investigational product to reduce aortic dissection false lumen perfusion.
Eligibility criteria
Qualifiers
≥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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- False Lumen Embolization System, IMPEDE-FX RapidFill