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

NCT06740721 | Not Yet Recruiting

• 1 other identifier: CRD1041
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Aortic Dissection

Outcome Measures

Primary Outcomes (2)

• Technical success

  Delivery and implantation of the investigational product implant to the false lumen

  Immediately after the intervention

• Major adverse events

  Incidence of device/procedure-related major adverse events

  30 days

Secondary Outcomes (6)

• All-cause mortality and dissection-related mortality

  2 years

• Serious adverse events

  2 years

• Change in false lumen thrombosis from baseline

  2 years

• Change in true lumen/aorta size ratio from baseline

  2 years

• Change in aorta size from baseline

  2 years

Study Arms (1)

Experimental: Intervention

EXPERIMENTAL

Device: False Lumen Embolization System Device: IMPEDE-FX RapidFill

Device: False Lumen Embolization System, IMPEDE-FX RapidFill

Interventions

False Lumen Embolization System, IMPEDE-FX RapidFill DEVICE

Embolization of the false lumen of an aortic dissection

Experimental: Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shape Memory Medical, Inc.: lead

MeSH Terms

Conditions

Aortic Dissection

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 18, 2024
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): January 4, 2027
• Study Completion (Estimated): January 3, 2029
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share