The Nellix® EndoVascular Aneurysm Sealing System for the Treatment of Infrarenal Abdominal Aortic Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 7
- 主要终点
- Safety- Number of Major Adverse Events
研究概览
简要总结
The purpose of this clinical study is to evaluate the safety and device performance of the Nellix® EndoVascular Aneurysm Sealing System (Nellix System) for the treatment of infrarenal abdominal aortic aneurysms.
详细描述
This is a multicenter, multi-country prospective, single-arm, non-randomized clinical trial. The comparative control arm is a combination of patient data drawn from the abdominal aortic aneurysms (AAA) open surgical control arms of four commercially approved AAA devices as part of the Society of Vascular Surgeons. Patients enrolled in this study will be pre-screened and have a diagnosis of an infrarenal AAA with or without the need for treatment of iliac artery aneurysm, are candidates for endovascular repair, and meet the eligibility criteria. Patients enrolled in the study will participate in follow-up visits 31 days, 6 months and at 1 year following the index procedure. At the follow-up visits there will be a clinical assessment, blood collection, and abdominal CT imaging of the patient.
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
- •At least 18 years of age
- •Informed consent form understood and signed and patient agrees to all follow-up visits
- •Is able and willing to comply with clinical follow-up requirements for one year
- •Is able and willing to undergo Contrast-Enhanced Spiral CT scans
- •Is a candidate for endovascular repair of an infrarenal aortic aneurysm with or without an iliac aneurysm with at least one of the following;
- •aneurysm ≥ 4.5 cm in diameter, or
- •aneurysm is twice the diameter of the normal infrarenal aorta, or
- •aneurysm is growing at a rate of ≥ 10 % per year
- •Non-aneurysmal aortic neck length ≥ 5mm below the most inferior renal artery
- •Proximal aortic neck diameter between 16 and 36mm
- •Aortic neck angulation to the sac ≤ 60
- •Common iliac artery diameter 8 to 35mm bilaterally
- •Aneurysm blood lumen diameter ≤ 60mm
- •Iliac and femoral arteries suitable for endovascular access with the Nellix System
排除标准
- •Life expectancy ≤ 1 year
- •Dissecting, ruptured, or leaking aneurysm (blood outside the aorta), has sustained recent trauma, is symptomatic, or is non-degenerative
- •Aneurysm is thoraco-abdominal, suprarenal and/or mycotic
- •Thoracic aneurysm ≥ 4.5cm in diameter
- •AAA requires treatment that would result in bilateral occlusion of the internal iliac arteries
- •Presence of mural thrombus > 50% circumferentially in aortic neck
- •Iliac aneurysm blood lumen diameter > 35mm
- •Active infection, vasculitis, or systemic connective tissue disease (e.g., Rheumatoid arthritis, scleroderma, Marfan's syndrome, Ehlers-Danlos disease) at time of procedure
- •History of prior treatment of abdominal aortic or iliac artery aneurysm disease
- •Femoral or iliac artery occlusive disease such that device delivery is not possible
- •Vascular access for delivery of device requires placement of vascular conduit or is through an established vascular graft
- •Receiving dialysis
- •History of hypercoagulability
- •Allergy to IV contrast
- •Serum creatinine level >2.0 mg/dL (or equivalent)
- •Patient is pregnant or nursing
- •Patient is currently enrolled in an investigational drug or device trial
结局指标
主要结局
Safety- Number of Major Adverse Events
时间窗: 30 day
The primary safety endpoint is defined as the incidence of Major Adverse Events (MAE) through 30 days after the index procedure.
Device Performance
时间窗: 30 days
The primary performance endpoint is technical success defined as successful delivery and deployment of the device and freedom from open surgical conversion at 30 days.
次要结局
- All Cause Mortality(12 months)