Surgeon-Modified Fenestrated/Branched Stent-Grafts for Treatment of Complex Aortic Aneurysms in High-Risk Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Determine the safety and effectiveness of sm-FBSG for the treatment of complex aortic aneurysms in patients at high-risk for open surgical repair.
研究概览
简要总结
This trial evaluates surgeon-modified fenestrated-branched stent-grafts (sm-FBSG) for Abdominal Aortic Aneurysms (AAA) that are custom-made intra-operatively with no waiting period by a qualified vascular surgeon. In addition, it aims to examine the alternative sm-FBSG for patients with restricted access to centers performing clinical trials with commercially available devices and those patients with aortic emergencies.
详细描述
Complex aortic aneurysms are those involving the renal and visceral arteries, and open repair of these aneurysms requires more extensive dissection, aortic clamping above the renal or mesenteric arteries, and possible reconstruction of aortic branches. Recovery time tends to be longer, including more hospital days, than for endovascular repair, and there is a greater potential for complications. Many high-risk patients with aneurysms of the abdominal aorta (AAA), including thoracoabdominal aortic aneurysms (TAAA), and significant co-morbidities will be denied elective open surgery because of heightened risks associated with open repair of complex aneurysms, and therefore, the potential benefit of an endovascular option increases as well.
Endovascular aneurysm repair has been shown to be an effective alternative in treating uncomplicated infrarenal and thoracic aneurysms in both the elective and urgent setting, yet there is limited experience with this technology in complex conditions. Fenestrated grafts have been developed as a minimally invasive treatment for patients with complex aortic aneurysms who are unfit for traditional open surgery.
Surgeon-modified fenestrated-branch stent grafts (sm-FBSG) with branches for the visceral vessels are custom-made by a qualified vascular surgeon for patients with complex aortic conditions. It is expected that they will minimize surgical risks and promote quicker recovery, and they could represent a therapeutic option for high-risk patients unfit for open surgery.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Determine the safety and effectiveness of sm-FBSG for the treatment of complex aortic aneurysms in patients at high-risk for open surgical repair.
时间窗: 30 Days
Major adverse events defined as: * All-cause death * Bowel ischemia * Myocardial infarction * Paraplegia * Renal failure * Respiratory failure * Stroke * Blood loss \>=1,000cc The primary effectiveness endpoint is the proportion of treatment group subjects that achieve treatment success. Treatment success is a composite endpoint assessed at 12 months that includes successful delivery and deployment of the graft with branch vessel preservation (technical success) as well as freedom from Type 1 and 3 endoleaks, graft migration, and AAA enlargement or rupture. Technical success is defined as successful delivery and deployment of the physician modified endovascular graft with preservation of those branch vessels intended to be preserved. Includes freedom from the following at 12 months: Type I \& III endoleak, stent graft migration, AAA enlargement, AAA rupture and conversion to open repair through 12 months.
次要结局
- Successful device delivery and deployment with patency of all branches(30 Days, 3 Months, 6 Months, and Years 1 to 5)
- Procedural / In-Hospital Evaluations(30 Days)
- Evaluate postoperative all-cause morbidity after repair with sm-FBSG(>30 Days to 5 Years)
- Evaluate long-term survival and complications after repair of complex aortic aneurysms with sm-FBSG(>30 Days to 5 Years)