Evaluation of the Clinical Performance of the Valiant Thoracic Stent Graft With the Captivia Delivery System for the Endovascular Treatment of Blunt Thoracic Aortic Injuries (RESCUE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 50
- 主要终点
- All-cause Mortality Within 30-days of the Index Procedure
研究概览
简要总结
The purpose of this study is to determine if the Valiant stent graft is safe and effective in treating patients who have a blunt thoracic aortic injury (BTAI). BTAI is when the aorta has been injured due to traumatic force to the chest area. It is commonly caused by motor vehicle accidents. In most cases it is life threatening and the standard treatment is surgery. Many times when a person has a BTAI they also have other injuries that can affect the results of the surgery.
Since stent grafting has been an effective way to treat other aortic conditions such as aneurysms (bulge in aorta wall), it is believed that the Valiant stent graft would be effective in treating BTAI. A stent graft is a woven polyester tube (graft) supported by a metal frame of strong but flexible nitinol (type of metal) springs (stent) that is placed in the aorta to help seal the injury and keep it from bleeding.
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
- •Subject had a blunt thoracic aortic injury which:
- •was confirmed, at a minimum, by diagnostic contrast-enhanced computerized tomography angiogram (CTA) and/or contrast-enhanced magnetic resonance angiogram (MRA)
- •occurred no more than 30 days prior to the stent implant procedure
- •Subject was ≥ 18 years of age
- •Subject or subject's legally authorized representative signed an IRB approved informed consent
- •Subject was hemodynamically stable
- •Subject's anatomy met all of the following anatomical criteria:
- •Aortic diameter (adventitia to adventitia) of the proximal and distal landing zones between 18 mm and 44 mm
- •Subject had patent iliac or femoral arteries or could tolerate an iliac conduit that allowed endovascular access to the injury site with the delivery system of the appropriate sized device
- •The centerline distance from the distal margin of left common carotid artery (LCC) to the injury was ≥ 20 mm
排除标准
- •Planned placement of the COVERED portion of the stent graft over the celiac axis or the LCC, or in cases of bovine anatomy, innominate artery
- •Subject had systemic infection
- •Subject was pregnant
- •Subject had received a previous stent or stent graft or previous surgical repair in the DTA
- •Subject had a history of bleeding diathesis, coagulopathy, or refuses blood transfusion
- •Subject was participating in an investigational drug or device clinical trial which would interfere with the endpoints and/or follow-ups of this study
- •Subject had a known allergy or intolerance to the device components
- •Subject had a known hypersensitivity or contraindication to anticoagulants or contrast media, which was not amenable to pre-treatment
- •Subject was in extremis, defined as subject that had non-survivable injury/condition
- •Subject had a Cerebral Vascular Accident (CVA) within two (2) months prior to implant procedure
结局指标
主要结局
All-cause Mortality Within 30-days of the Index Procedure
时间窗: 30 days
次要结局
未报告次要终点