NCT07387250尚未招募不适用
False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15
- 主要终点
- Technical success
研究概览
简要总结
To determine the safety and feasibility of the investigational product to reduce aortic dissection false lumen perfusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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.
排除标准
- •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.
研究组 & 干预措施
Experimental: Intervention
Experimental
Device: False Lumen Embolization System Device: IMPEDE-FX RapidFill
干预措施: False Lumen Embolization System, IMPEDE-FX RapidFill (Device)
结局指标
主要结局
Technical success
时间窗: Immediately after the intervention
Delivery and implantation of the investigational product implant to the false lumen
Major adverse events
时间窗: 30 days
Incidence of device/procedure-related major adverse events
次要结局
- All-cause mortality and dissection-related mortality(2 years)
- Serious adverse events(2 years)
- Change in false lumen thrombosis from baseline(2 years)
- Change in true lumen/aorta size ratio from baseline(2 years)
- Change in aorta size from baseline(2 years)
- Rate of dissection-related reinterventions(2 years)
研究者
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