Clinical Trial

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

Study acronym: FLAGSHIP_NZL
Recruiting
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Summary
To determine the safety and feasibility of the investigational product to reduce aortic dissection false lumen perfusion.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2024-08-09; most recent amendment 2026-03-19.
Status change: Not Yet Recruiting → Recruiting 2026-03-19
Trial Details
NCT Number NCT06550986
Lead Sponsor Shape Memory Medical, Inc.
Conditions Aortic Dissection
Enrollment 30 participants
Start Date 2026-02-24
Primary Completion 2027-02-15 (estimated)
Study Completion 2029-02-15 (estimated)
Updated on ClinicalTrials.gov 2026-03-23