NCT06550986 False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study

Eligibility & Interventions

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You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 30 participants in total. It began in 2026-02-24 with a primary completion date of 2027-02-15.

Brief Summary

To determine the safety and feasibility of the 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 \>220 µmol/L (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.

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