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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Aortic Dissection
• Intervention / Treatment: Device: False Lumen Embolization System, IMPEDE-FX RapidFill

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ≥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.

Exclusion Criteria:

• 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).
• Vascular disease, aortic rupture, and/or anatomy and/or dissection membrane condition that precludes the safe access and positioning of an introducer sheath and delivery (and expansion) of the investigational product into the FL.
• Prior treatment of the FL.
• Planned use of investigational devices to treat the primary entry tear and/or TL.
• Absence of/inability to create a reentry tear/fenestration adequately positioned and large enough to allow introducer sheath access into the FL.
• Planned use of FL embolic devices other than the investigational product.
• Prior abdominal aortic aneurysm (AAA) treatment.
• Planned concomitant major surgery (e.g., gastrointestinal surgery).
• Diagnosed or suspected congenital degenerative connective tissue disease (e.g., Marfan's or Ehler-Danlos syndrome).
• Coagulopathy or uncontrolled bleeding disorder.
• Serum creatinine level >2.5 mg/dL (within 90 days prior to the procedure).
• Cerebrovascular accident within 90 days prior to the procedure.
• Myocardial infarction and/or major heart surgery within 90 days prior to the procedure.
• Atrial fibrillation that is not well rate controlled.
• Unable or unwilling to comply with study follow-up requirements.
• Life expectancy of <2 years postprocedure.
• Known hypersensitivity or contraindication to platinum, iridium, or polyurethane.
• A condition that inhibits radiographic visualization during the study procedure and planned follow-up imaging.
• History of allergy to contrast medium that cannot be managed medically.
• Uncontrolled comorbid medical condition, including mental health issues, that, in the opinion of the investigator, would adversely affect participation in the study.
• Participant is planning to become pregnant or is currently pregnant or lactating. For participants of child-bearing potential, based on a positive pregnancy test within 7 days prior to the procedure or refusal to use a medically accepted method of birth control for the duration of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Intervention; Device: False Lumen Embolization System Device: IMPEDE-FX RapidFill	Device: False Lumen Embolization System, IMPEDE-FX RapidFill; Embolization of the false lumen of an aortic dissection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse events	Incidence of device/procedure-related major adverse events	30 days
Technical success	Delivery and implantation of the investigational product implant to the false lumen	Immediately after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality and dissection-related mortality	Incidence of all-cause mortality and dissection-related mortality	2 years
Serious adverse events	Incidence of device/procedure-related serious adverse events	2 years
Change in false lumen thrombosis from baseline	Change in false lumen thrombosis from baseline	2 years
Change in true lumen/aorta size ratio from baseline	Change in true lumen/aorta size ratio from baseline	2 years
Change in aorta size from baseline	Change in aorta size from baseline	2 years
Rate of dissection-related reinterventions	Rate of dissection-related reinterventions	2 years

Collaborators and Investigators

• Sponsor: Shape Memory Medical, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: January 27, 2026
• First Submitted That Met QC Criteria: January 27, 2026
• First Posted (Actual): February 4, 2026

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Dissection, Blood Vessel; Acute Aortic Syndrome; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Dissection
• Other Study ID Numbers: CRD1063

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No