Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix System IDE Study (EVAS 2 Confirmatory IDE Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Endologix
- 入组人数
- 98
- 试验地点
- 53
- 主要终点
- Safety: Major Adverse Events (MAE)
研究概览
简要总结
Prospective, multicenter, single arm study with consecutive, eligible subject enrollment at each site. All subjects will undergo the Endovascular Aneurysm repair procedure with the Nellix System.
详细描述
This study will evaluate the safety and effectiveness of the Nellix System among a wide range of physicians and in consecutively enrolled subjects to assess safety and effectiveness outcomes. Following appropriate government and ethics committee/IRB approval the Nellix® EndoVascular Sealing System will be implanted into eligible patients who are adequately informed and have consented to join the study. Enrolled patients 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.
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
- •A patient who meets all of the following criteria potentially may be included in the study:
- •Male or female at least 18 years old;
- •Informed consent form understood and signed
- •Patient agrees to all follow-up visits;
- •Abdominal aortic aneurysm with sac diameter ≥5.0cm, or ≥4.5cm which has increased by ≥0.5cm within the last 6 months, or or which exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment. No AAA <4 cm will be included.
- •Anatomically eligible for the Nellix System (per Instructions For Use):
- •Adequate iliac/femoral access compatible with the required delivery systems (diameter ≥6 mm);
- •Aneurysm blood lumen diameter ≤60mm;
- •Proximal non-aneurysmal aortic neck: length ≥10mm; diameter 18 to 28mm; angle ≤60° to the aneurysm sac;
- •Most caudal renal artery to each hypogastric artery length ≥100mm;
- •Common iliac artery lumen diameter between 9 and 35mm;
- •Distal iliac artery seal zone with length of ≥10mm and diameter range of 9 to 25mm;
- •Ability to preserve at least one hypogastric artery.
- •Ratio of maximum aortic aneurysm diameter to maximum aortic blood lumen diameter <1.40
排除标准
- •A patient who meets none of the following criteria potentially may be included in the study:
- •Life expectancy <2 years as judged by the Investigator;
- •Psychiatric or other condition that may interfere with the study;
- •Participating in another clinical study;
- •Known allergy or contraindication to any device material;
- •Coagulopathy or uncontrolled bleeding disorder;
- •Ruptured, leaking or mycotic aneurysm;
- •Serum creatinine (S-Cr) level >2.0 mg/dL;
- •CVA or MI within three months of enrollment/treatment;
- •Aneurysmal disease of the descending thoracic aorta;
- •Clinically significant mural thrombus within the proximal landing zone (minimum 10mm) of the infrarenal non-aneurysmal neck (>5mm thickness over >50% circumference);
- •Connective tissue diseases (e.g., Marfan Syndrome);
- •Unsuitable vascular anatomy that may interfere with device introduction or deployment;
- •Pregnant (female of childbearing potential only).
研究组 & 干预措施
Single Arm
Single Arm Safety and Effectiveness Confirmatory Study of EVAS using the Nellix® System
干预措施: Nellix® System (Device)
结局指标
主要结局
Safety: Major Adverse Events (MAE)
时间窗: 30 days
The primary safety endpoint is defined as the incidence of Major Adverse Events (MAE) at 30 days, defined as the composite of the following All-Cause Mortality; Bowel Ischemia; Myocardial Infarction; Paraplegia; Renal Failure; Respiratory Failure; Stroke; Procedural Blood Loss ≥1,000cc
Effectiveness: Rate of Treatment Success
时间窗: 2 year
The primary effectiveness endpoint is defined as the rate of Treatment Success at year 2. Treatment Success is a composite of outcomes clinically relevant to the endovascular repair of infrarenal AAA as follows: It is defined as procedural technical success and absence of Abdominal aortic aneurysm rupture; Conversion to open surgical repair; Endoleak Type I or III at year 2; Clinically significant migration; \> 5mm aneurysm sac enlargement of the maximal diameter as measured by the difference from the 30-Day CT time point; or Secondary endovascular procedure up to year 2 for resolution of Endoleak (Type I or Type III), Device obstruction or occlusion, Device migration, Abdominal aneurysm sac expansion, Device defect.
次要结局
- LABS-RENAL FUNCTION (EGFR)(2 Years)
- LABS- RENAL FUNCTION (CREATININE)(2 Years)
- Conversions, Death and Ruptures(2 Years)
- Device Integrity(2 Years)
- Device Performance - Endoleak(2 Years)
- DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Avg Size(2 years)
- DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Changes in Sac Size Since 01 Month(2 Years)
- Secondary Interventions(2 Years)