Actively Recruiting
False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study
Led by Shape Memory Medical, Inc. · Updated on 2026-03-23
30
Participants Needed
2
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To determine the safety and feasibility of the investigational product to reduce aortic dissection false lumen perfusion.
CONDITIONS
Official Title
False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Candidate for false lumen embolization with a type B dissection and no prior primary entry tear or true lumen treatment
- Candidate for false lumen embolization with a type B or type A dissection previously treated for the primary entry tear or true lumen, now requiring false lumen treatment
You will not qualify if you...
- Unable to provide informed consent
- Enrolled in another clinical study except a registry
- Hyperacute or acute aortic dissection less than 15 days from symptom onset
- Untreated or uncovered primary entry/reentry tear proximal to left subclavian artery before false lumen treatment
- Vascular disease, aortic rupture, or anatomy preventing safe access or delivery of the investigational product
- Prior treatment of the false lumen
- Planned use of other investigational devices for primary entry tear or true lumen
- Absence of or inability to create a suitable reentry tear/fenestration for access into the false lumen
- Planned use of false lumen embolic devices other than the investigational product
- Prior abdominal aortic aneurysm treatment
- Planned major surgery such as gastrointestinal surgery
- Diagnosed or suspected congenital degenerative connective tissue disease like Marfan's or Ehler-Danlos syndrome
- Coagulopathy or uncontrolled bleeding disorder
- Serum creatinine over 220 �b5mol/L within 90 days prior to procedure
- Stroke within 90 days prior to procedure
- Heart attack or major heart surgery within 90 days prior to procedure
- Atrial fibrillation not well rate controlled
- Unable or unwilling to comply with study follow-up
- Life expectancy less than 2 years postprocedure
- Known allergy or contraindication to platinum, iridium, or polyurethane
- Condition preventing radiographic visualization during procedure and follow-up
- History of allergy to contrast medium not medically manageable
- Uncontrolled medical or mental health condition affecting participation
- Planning pregnancy, currently pregnant, or lactating; refusal to use accepted birth control if of child-bearing potential
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Auckland City Hospital
Auckland, New Zealand, 1023
Actively Recruiting
2
Waikato Hospital
Hamilton, New Zealand, 3204
Actively Recruiting
Research Team
P
Peter Miller, M.S.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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