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

NCT06740721 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-01-29

No results posted yet for this study

Summary

To determine the safety and feasibility of investigational product to reduce aortic dissection false lumen perfusion.

Conditions

  • Aortic Dissection

Interventions

DEVICE

False Lumen Embolization System, IMPEDE-FX RapidFill

Embolization of the false lumen of an aortic dissection

Sponsors & Collaborators

  • Shape Memory Medical, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2027-01-04
Completion
2029-01-03

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06740721 on ClinicalTrials.gov