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

Launched by SHAPE MEMORY MEDICAL, INC. · Dec 13, 2024

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ClinConnect Summary

The FLAGSHIP_FRA trial is a medical study aimed at testing a new treatment designed to help patients with aortic dissection, a serious condition where there is a tear in the aorta, the large blood vessel that carries blood from the heart. Specifically, this study is looking at a special product that may help reduce blood flow in the false lumen, which is an area created by the tear that can cause further complications. Researchers want to see if this treatment is safe and if it works well in people with this condition.

To participate in this trial, you need to be at least 18 years old and meet certain health criteria, such as being diagnosed with a type B aortic dissection needing treatment, or having had previous treatment for a related tear. Unfortunately, some people may not be eligible, such as those who have recently experienced severe aortic issues or have certain other health conditions. If you qualify and choose to join, you will receive the investigational product and be monitored closely by the medical team throughout the study to ensure your safety and to gather important information about the treatment. Remember, this study is still in the planning stages and is not yet recruiting participants.

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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.