False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study (FLAGSHIP_FRA)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShape Memory Medical, Inc.

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

Treatment groups

15 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators