Clinical trial NCT06740721: False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study (FLAGSHIP_FRA)
Official title: False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Aortic Dissection
Lead sponsor: Shape Memory Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2024-12-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Technical success
timeFrame: Immediately after the intervention
measure: Major adverse events
timeFrame: 30 days
Secondary outcomes:
measure: All-cause mortality and dissection-related mortality
timeFrame: 2 years
measure: Serious adverse events
timeFrame: 2 years
measure: Change in false lumen thrombosis from baseline
timeFrame: 2 years
measure: Change in true lumen/aorta size ratio from baseline
timeFrame: 2 years
measure: Change in aorta size from baseline
timeFrame: 2 years
measure: Rate of dissection-related reinterventions
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References: