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
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and feasibility of a new device called the False Lumen Embolization System (IMPEDE-FX RapidFill) to reduce blood flow into the false lumen in patients with aortic dissection. This first-in-human study aims to prevent the growth of the aorta by treating the false lumen, which is a common concern in this condition. The sponsor leading this study is Shape Memory Medical, Inc. Participants will receive treatment using the investigational device designed to block the false lumen of the aorta. The study involves a single experimental group where the device will be delivered to the affected area to achieve embolization. The treatment is performed once, and its technical success will be assessed immediately after the procedure. The study does not include placebo or comparison groups. During the study, participants will be closely monitored for technical success right after the intervention and for major adverse events up to 30 days post-treatment. Follow-up evaluations will continue for up to two years to track mortality, serious adverse events, changes in the false lumen and aorta size, and the need for any further interventions. Various imaging and clinical assessments will be used throughout the follow-up period to evaluate the device's impact and participant safety.
CONDITIONS
Brief 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, OR
- Candidate for false lumen embolization with a type B or type A dissection who had prior primary entry tear or true lumen treatment and now requires false lumen treatment
You will not qualify if you...
- Unable to provide informed consent
- Enrolled in another clinical study other than a registry
- Hyperacute or acute aortic dissection (less than 15 days from symptom onset)
- Untreated or uncovered primary entry or reentry tear proximal to left subclavian artery before false lumen treatment
- Vascular disease, aortic rupture, or anatomical conditions preventing safe delivery of the investigational device
- Prior treatment of the false lumen
- Planned use of investigational devices to treat the primary entry tear or true lumen
- Inability to create or absence of a suitable reentry tear for device access
- Planned use of false lumen embolic devices other than the investigational product
- Prior abdominal aortic aneurysm treatment
- Planned major surgery during the study period
- Diagnosed or suspected congenital degenerative connective tissue disease (e.g., Marfan's or Ehler-Danlos syndrome)
- Coagulopathy or uncontrolled bleeding disorder
- Serum creatinine level over 220 µmol/L within 90 days prior to procedure
- Stroke within 90 days prior to procedure
- Recent myocardial infarction or major heart surgery within 90 days prior to procedure
- Poorly controlled atrial fibrillation
- Unable or unwilling to comply with study follow-up
- Life expectancy less than 2 years post-procedure
- Known allergy or contraindication to platinum, iridium, or polyurethane
- Condition preventing radiographic visualization during procedure and follow-up
- Allergy to contrast medium not manageable medically
- Uncontrolled medical or mental health condition affecting participation
- Currently pregnant, lactating, or planning pregnancy without medically accepted birth control during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo embolization of the false lumen of an aortic dissection using the False Lumen Embolization System Device.
1 procedure visit (in-person)
Duration - 2 years
Participants are monitored for safety and effectiveness of the device including adverse events and changes in aortic size over 2 years.
Multiple follow-up visits over 2 years
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.
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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