Prospective, Multicenter, Non-randomized Study With Consecutive, Eligible Subject Enrollment at Each Site, for the Evaluation of the ChEVAS System for Endovascular Repair of Paravisceral, Juxtarenal, and Pararenal Abdominal Aortic Aneurysms.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Endologix
- 入组人数
- 13
- 试验地点
- 15
- 主要终点
- Proportion of Technical Success, Safety and Effectiveness Indicators at One-Month Post-Index Procedure
研究概览
简要总结
Prospective, multi-center, non-randomized study with consecutive, eligible subject enrollment at each site, for the evaluation of the ChEVAS System for Endovascular Repair of Complex Abdominal Aortic Aneurysms.
详细描述
This is a prospective multicenter study with consecutive eligible subject enrollment at each site. Enrollment will include up to 150 subjects (120 ChEVAS subjects and up to 30 infrarenal roll-in subjects). The ChEVAS study will evaluate the safety and effectiveness outcomes following appropriate government and ethics committee/IRB requirements and guidelines.
All enrolled (ChEVAS and Infrarenal) subjects will undergo a high resolution, contrast-enhanced computed tomography angiography (CT) scan of the relevant aortic and aortoiliac vasculature within three months of the scheduled procedure and at specified follow-up intervals post-implantation. Follow-up visits will occur at 30-days, 6-months, and annually to 5-years to assess aneurysm morphology, the status of the implanted devices, and relevant laboratory test results.
*As of October 27, 2021 ChEVAS ONE Study is voluntarily closed to screening and consenting. 13 subjects enrolled in the study will continue to be observed through 5-years.
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
- •Adults at least 18-years old
- •Subject provided informed consent
- •Subject agrees to all follow-up visits
- •Abdominal aortic aneurysm (AAA) with maximum sac diameter ≥5.0 cm, or ≥ 4.5 cm which has increased by ≥ 0.5cm within the last 6-months, or which exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment. No AAA <4cm will be included
- •Absence of significant cranial angulation of the visceral vessels that would preclude vessel cannulation and stenting
排除标准
- •Requirement of home oxygen
- •Psychiatric or other condition that may interfere with the study
- •Participating in another clinical drug and/or device study, which could confound the results of this study (patient must have completed the primary endpoint of any previous study at least 30-days prior to enrollment in this study)
- •Known allergy or contraindication to any device material, contrast, or anticoagulants
- •Serum creatinine level >1.8mg/dL
- •CVA or MI within three months of enrollment/treatment
- •Prior stent in any target visceral vessel, the aorta or iliac artery that may interfere with delivery system introduction or stent placement
- •Connective tissue diseases (e.g., Marfan Syndrome)
- •Unsuitable vascular anatomy that may interfere with device introduction or deployment
- •Pregnant, planning to become pregnant within 60 months, or breast feeding.
研究组 & 干预措施
ChEVAS System
The ChEVAS procedure involves the use of the Nellix System in conjunction with parallel branch chimney stents for the treatment of juxtarenal, pararenal, or paravisceral abdominal aortic aneurysms.
干预措施: Chimney Endovascular Aortic Sealing (ChEVAS) System (Device)
结局指标
主要结局
Proportion of Technical Success, Safety and Effectiveness Indicators at One-Month Post-Index Procedure
时间窗: 1-Month
The outcome at one-month post index procedure will be measured by the proportion of subjects that experience technical success and the absence of severe bowel ischemia, permanent paraplegia/paraparesis, renal failure, disabling stroke, abdominal aortic aneurysm rupture, and aneurysm-related mortality within 30-days of the index procedure.
Proportion of Safety and Effectiveness Indicators at One-Year Post-Index Procedure
时间窗: 1-Year
The outcome at one-year post index procedure will be measured by the proportion of subjects that experience freedom from abdominal aortic aneurysm rupture and aneurysm-related mortality up until 1-year (day 365), freedom from imaging-related findings in the 1-year window (Type 1 or 3 endoleak, migration \> 10mm, AAA sac expansion \> 5mm, and occlusion within the ChEVAS System not seen at the index procedure), and open conversion through day 365.
次要结局
未报告次要终点