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

Официальное название

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

Обзор

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

Вмешательства

• Устройство False Lumen Embolization System, IMPEDE-FX RapidFill
  Embolization of the false lumen of an aortic dissection

Первичные конечные точки

• Technical success [Срок оценки: Immediately after the intervention]
• Major adverse events [Срок оценки: 30 days]

Вторичные конечные точки (6)

• All-cause mortality and dissection-related mortality [Срок оценки: 2 years]
• Serious adverse events [Срок оценки: 2 years]
• Change in false lumen thrombosis from baseline [Срок оценки: 2 years]
• Change in true lumen/aorta size ratio from baseline [Срок оценки: 2 years]
• Change in aorta size from baseline [Срок оценки: 2 years]
• Rate of dissection-related reinterventions [Срок оценки: 2 years]

Критерии участия

Критерии включения

• ≥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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06740721 · CRD1041

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗