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

Not Applicable

Not yet recruiting

• Conditions: Aortic Dissection

• Registration Number: NCT06740721
• Lead Sponsor: Shape Memory Medical, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-12-13
• Study First Submitted QC: 2024-12-13
• Study First Posted: 2024-12-18
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-11
• Study Start: 2025-12-01
• Primary Completion: 2026-06-01
• Study Completion: 2028-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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