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NCT06550986 | NOT YET RECRUITING | Aortic Dissection

False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study
Sponsor:

Shape Memory Medical, Inc.

Brief Summary:

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

Condition or disease

Aortic Dissection

Intervention/treatment

False Lumen Embolization System, IMPEDE-FX RapidFill

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 15 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study
Actual Study Start Date : 2025-05-01
Estimated Primary Completion Date : 2025-09-01
Estimated Study Completion Date : 2027-09-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study

Location Details

NCT06550986

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

New Zealand,

Auckland City Hospital

Auckland, New Zealand,