NCT01114724已完成不适用
Valiant® Thoracic Stent Graft With the Captivia Delivery System. Evaluation of the Clinical Performance of the Valiant Thoracic Stent Graft With the Captivia Delivery System (Valiant Captivia) for the Treatment of Acute, Complicated Type B Aortic Dissections
Medtronic Cardiovascular33 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2010年5月1日最近更新:
适应症
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
- 33
- 主要终点
- All Cause Mortality.
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 thoracic dissection. A thoracic dissection is a tear in the wall of the aorta, that causes blood to flow between the layers of the aorta and force the layers apart (dissect). This condition is a medical emergency and can quickly lead to death. 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 device would be effective in treating dissections. Information will be collected on the performance of the device for 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
- •Subject signed an informed consent.
- •Subject is at least 18 years old.
- •Subject has an acute, complicated Type B aortic dissection with evidence of at least one of the following:
- •Malperfusion (visceral, renal, spinal cord and/or lower limb ischemia)
- •Visceral ischemia measured by either radiographic or clinical evidence.
- •Renal ischemia measured by either radiographic or clinical evidence.
- •Spinal cord ischemia measured by either radiographic or clinical evidence.
- •Lower limb ischemia measured by either radiographic or clinical evidence.
- •Rupture - Measured by radiographic or clinical evidence.
- •Subject is hemodynamically stable.
- •Subject's anatomy must meet all of the following anatomical criteria:
- •Proximal landing zone aortic diameter must be between 20 mm and 44 mm;
- •Centerline distance from distal margin of left CCA or in cases of bovine anatomy, innominate artery, to start of most proximal tear must be ≥ 20 mm;
- •Subject has patent iliac or femoral arteries or can tolerate an iliac conduit that allows endovascular access to the dissection site with the delivery system of the appropriate sized device.
- •Thoracic aortic dissection is confirmed, at a minimum, by diagnostic contrast-enhanced computerized tomography angiogram (CTA) with 3-D reconstruction, and/or contrast enhanced magnetic resonance angiogram (MRA) obtained prior to the implant procedure.
排除标准
- •Planned placement of the COVERED portion of the stent graft over the left carotid artery, or the celiac trunk.
- •Subject has systemic infection.
- •Subject is pregnant.
- •Subject has received a previous stent or stent graft or previous surgical repair in the DTA.
- •Subject has had a cerebral vascular accident (CVA) within 2 months.
- •Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion.
- •Subject has a history of Marfan Syndrome or other connective tissue disorder.
- •Subject is currently participating in an investigational drug or device clinical trial which would interfere with the endpoints and follow-ups of this study.
- •Subject has a known allergy or intolerance to the device components.
- •Subject has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.
- •Subject has a co-morbidity causing expected survival to be less than 1 year.
结局指标
主要结局
All Cause Mortality.
时间窗: Up to 30 days after the stent graft implant.
次要结局
- All-cause Mortality(at 12 months)
- Subjects With Successful Delivery and Deployment of the Device.(At implant.)
- Subjects With Coverage of Primary Tear(At implant)
- Aortic Rupture(Within 12 months)
- Subjects With Secondary Endovascular Procedures(Through12 months)
- Aortic Remodeling: Subjects With Partial/Complete False Lumen Thrombosis Over the Stented Segment(At 6 months)
- Aortic Remodeling: Subjects With Stable (+/- 5mm) or Decrease in False Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft(at 12 months)
- Aortic Remodeling: Subjects With Complete/Partial Thrombosis of the False Lumen Over the Stented Segment(At 12 months)
- Aortic Remodeling: Subjects With Stable (+/- 5mm) or Increase in True Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft(at 12 months)
- Subjects With Device, Procedure and/or Aortic Related Serious Adverse Events.(at 12 months)
研究者
研究点 (33)
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