Status:
NOT_YET_RECRUITING
False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study
Lead Sponsor:
Shape Memory Medical, Inc.
Conditions:
Aortic Dissection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To determine the safety and feasibility of the investigational product to reduce aortic dissection false lumen perfusion.
Eligibility Criteria
Inclusion
- ≥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
- 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.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06550986
Start Date
December 1 2025
End Date
June 1 2028
Last Update
May 11 2025
Active Locations (1)
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1
Auckland City Hospital
Auckland, New Zealand