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

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.