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

Launched by SHAPE MEMORY MEDICAL, INC. · Aug 9, 2024

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ClinConnect Summary

This clinical trial is looking at a new treatment for people with aortic dissection, a serious condition where the inner layer of the aorta (the large artery that carries blood from the heart) tears. The goal is to see if a special material can help reduce blood flow in the false lumen, which is the space created by the tear. This is the first time this treatment is being tested in humans, and researchers want to make sure it is safe and can be done successfully.

To participate in the trial, you need to be at least 18 years old and have a type B or type A aortic dissection. You should not have had previous treatment for the primary tear or the false lumen unless it was successfully treated before. There are some health conditions that may exclude you from joining, such as certain heart issues or uncontrolled bleeding disorders. If you decide to join, you will undergo the new treatment and will be monitored closely to ensure your safety throughout the study. It's important to note that the trial is not yet recruiting participants, so there will be more information available as it gets closer to starting.

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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 \>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.