NCT04751578进行中（未招募）不适用
Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks - A Prospective Multicenter Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 试验地点
- 6
- 主要终点
- Incidence of related major adverse events (MAEs)
研究概览
简要总结
To determine the safety and efficacy of IMPEDE-FX Embolization Plug and/or IMPEDE-FX Rapid Fill to fill an abdominal aortic aneurysm (AAA) sac outside of an endovascular aneurysm repair (EVAR) stent graft.
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 elective EVAR of an infrarenal aortic aneurysm ≥5.5 cm in diameter in men and ≥5.0 cm in women
排除标准
- •An inability to provide informed consent
- •Enrolled in another clinical study
- •Aortoiliac aneurysm, or concomitant iliac artery ectasia or aneurysm (common iliac artery diameter >24 mm) close to the bifurcation and/or that cannot be adequately sealed
- •Patent AAA sac feeding vessels (within the sac) >4 mm in diameter
- •Volume of AAA sac to be filled after stent graft placement <20 mL or >135 mL, based on pre-procedure CTA (i.e. aortic flow volume exclusive of stent graft volume)
- •Use of aortic stent grafts other than the Gore Excluder AAA Endoprosthesis, Cook Zenith Flex AAA Endovascular Graft, or Medtronic Endurant II Stent Graft to treat the AAA
- •Planned use of the chosen stent graft outside its instructions for use (IFU)
- •Planned use of fenestrated or chimney stent grafts
- •Study participants in which stent graft placement is abandoned for any reason, and/or in which the investigator decides, during the course of the stent graft placement, that the study procedure may not be appropriate
- •Planned use of embolic devices other than the investigational product to embolize the AAA sac
- •Vascular disease and/or anatomy that preclude the safe access and positioning of a catheter to deliver the investigational product into the AAA sac
- •Ruptured, leaking, or mycotic (infected) aneurysm
- •Aneurysmal disease of the descending thoracic aorta
- •Coagulopathy or uncontrolled bleeding disorder
- •Long-term (>6 months prior to the procedure) use of direct oral anticoagulant or any vitamin K antagonist anticoagulant use
- •Serum creatinine level >2.5 mg/dL;
- •Cerebrovascular accident within 3 months prior to the procedure
- •Myocardial infarction and/or major heart surgery within 3 months 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 post-procedure
- •Known hypersensitivity or contraindication to platinum, iridium, or polyurethane
- •A condition that inhibits radiographic visualization during the implantation procedure
- •History of allergy to contrast medium that cannot be managed medically
- •Uncontrolled co-morbid medical condition, including mental health issues, that would adversely affect participation in the study
- •Pregnant or a lactating female. For females 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
- •Prisoner or member of other vulnerable population.
结局指标
主要结局
Incidence of related major adverse events (MAEs)
时间窗: 30 days post-procedure
Incidence of related major adverse events (MAEs)
Efficacy - Technical Success
时间窗: Immediately after the intervention
Technical success, defined as filling of the residual flow lumen of the AAA sac with investigational products
次要结局
- Incidence of related major adverse events (MAEs)(5 years post-procedure)
- Incidence of related serious adverse events (SAEs)(5 years post-procedure)
- Efficacy - Open repair(5 years post-procedure)
- Efficacy - Reinterventions(5 years post-procedure)
- Efficacy - Type II endoleaks(5 years post-procedure)
- Efficacy - Type I and type III endoleaks(5 years post-procedure)
- Efficacy - AAA sac diameter/volume(5 years post-procedure)
研究者
研究点 (6)
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