Endurant CHevAr New Indication Trial: ENCHANT - Post-market Study of the Endurant CHEVAR Technique for the Treatment of Juxtarenal Aortic Aneurysms With a Short Infrarenal Neck
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
- 试验地点
- 52
- 主要终点
- Primary safety endpoint evaluated by proportion of subjects experiencing a Major Adverse Event through 30 days post-index procedure
研究概览
简要总结
The purpose of the post-market study is to assess the clinical outcomes, safety, and performance of the Endurant Chimney Graft Technique (Endurant Stent Graft Systems used with a balloon-expandable covered stent graft) for treatment of juxtarenal aortic aneurysms with a short infrarenal neck in a real world setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Subject is ≥18 years old
- •Subject is scheduled for primary treatment of the juxtarenal aortic aneurysm with a short infrarenal neck (i.e. no revision subjects)
- •Subject is able and willing to comply with the protocol and to adhere to the follow-up requirements
- •Subject has provided written informed consent
- •Subject is an eligible candidate according to the currently available Endurant II/IIs instructions for use for ChEVAR
- •Subject has a juxtarenal aortic aneurysm with a short infrarenal neck (definition of juxtarenal aortic aneurysm with a short infrarenal neck will be in accordance with commercially available Endurant II/IIs instructions for use for ChEVAR).
排除标准
- •Subject is participating in a concurrent study which may confound study results
- •Subject has a life expectancy ≤ 2 year
- •Subject has an aneurysm that is:
- •Suprarenal or pararenal
- •Isolated iliofemoral
- •Inflammatory
- •Pseudoaneurysm
- •Subject requires emergent aneurysm treatment, for example, trauma or rupture
- •Subject has previously undergone surgical treatment for abdominal aortic aneurysm
- •Subject is a female of childbearing potential in whom pregnancy cannot be excluded
- •Subject has a known hypersensitivity or contraindication to anticoagulants, anti-platelets, or contrast media, which is not amenable to pre-treatment
- •Subject has a creatinine level >2.0 mg/dl (or >176.8 μmol/L) and/or is on dialysis
- •Subject has an active COVID-19 infection or relevant history of COVID-
- •Relevant history of COVID-19 is defined as availability of a positive COVID-19 test with sequela or hospitalization for treatment of COVID-
- •Subjects with a positive COVID-19 test who were asymptomatic or had mild symptoms should be excluded only if the positive test was less than 6 months prior to enrollment
结局指标
主要结局
Primary safety endpoint evaluated by proportion of subjects experiencing a Major Adverse Event through 30 days post-index procedure
时间窗: through 30 days post-index procedure
Major Adverse Events include the occurrence of any of the following events: * All-cause mortality * Bowel ischemia * Myocardial infarction * Paraplegia * Procedural blood loss ≥1000 cc * Renal failure * Respiratory failure * Stroke
The primary performance endpoint is defined as the proportion of subjects who have technical success at the time of the index procedure and are free from secondary interventions through 365 days.
时间窗: Index procedure and through 365 days
次要结局
- Secondary safety endpoints(through 30 days and annually up to 5 year follow up)
- Secondary imaging based endpoints(at 30 days and at annual follow-up until 60 months post-index procedure)
- Clinical Succes(Index procedure and within 30-days post-index procedure)
- Change in renal function(at 30 days and at annual follow-up until 60 months post-index procedure)