NCT00874250已完成不适用
An Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for the Primary Treatment of Aneurysm of the Descending Thoracic Aortic
W.L.Gore & Associates2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2009年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- The Number of Subjects Free From a Major Device Event Through 1 Month Post-treatment
研究概览
简要总结
To assess the safety and efficacy of the GORE Conformable TAG® Thoracic Endoprosthesis in the primary treatment of aneurysm of the descending thoracic aorta (DTA)
> Primary Hypothesis: The proportion of subjects free from a major device event through 1 month post-treatment will not be significantly less than 0.95, which represents the proportion observed in previous clinical studies with the GORE TAG® Thoracic Endoprosthesis
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of DTA aneurysm deemed to warrant surgical repair >
- •Fusiform (≥50 mm), or >
- •Saccular (no diameter criteria)>
- •Subject is > 21 years of age>
- •Proximal and distal landing zone length ≥ 2.0 cm >
- •Landing zones must be in native aorta>
- •Landing zone may include left subclavian artery, if necessary>
- •All proximal and distal landing zone inner diameters are between 16-42 mm>
- •Diameter assessed by flow lumen and thrombus, if present; calcium excluded>
- •Life expectancy > 2 years>
- •Able to tolerate thoracotomy >
- •Male or infertile female>
- •Able to comply with protocol requirements including following-up>
- •Signed informed consent>
排除标准
- •Differing proximal and distal neck diameters (aortic taper) outside the intended aortic diameter requirements (sizing guide) for a single endoprosthesis diameter and the inability to use devices of different diameters (in adherence to the sizing guide) to compensate for the taper>
- •Tortuous or stenotic iliac and/or femoral arteries and inability to use a conduit for vascular access>
- •Aneurysmal, dissected, heavily calcified, or heavily thrombosed landing zone(s)>
- •Mycotic aneurysm>
- •Hemodynamically unstable aneurysm rupture>
- •Aortic dissection>
- •Planned coverage of left carotid or celiac arteries with the CTAG Device>
- •Planned concomitant surgical procedure (other than left subclavian transposition and wireless sac pressure monitoring), or major surgery within 30 days of treatment date>
- •Known degenerative connective tissue disease, e.g. Marfan or Ehler-Danlos Syndrome>
- •Known history of drug abuse>
- •ASA risk classification = V (moribund patient not expected to live 24 hours with or without operation)>
- •NYHA class IV >
- •Participating in another investigational device or drug study within 1 year of treatment>
- •Subject has known sensitivities or allergies to the device materials>
- •Subject has a systemic infection and may be at increased risk of endovascular graft infection>
研究组 & 干预措施
GORE CTAG Device
Experimental
The primary endpoint of this study is freedom from a Major Device Event (MDE) through 1 month post-treatment in subjects treated with the GORE® Conformable TAG® Thoracic Endoprosthesis.
干预措施: GORE CTAG Device (Device)
结局指标
主要结局
The Number of Subjects Free From a Major Device Event Through 1 Month Post-treatment
时间窗: Treatment through 1 month post treatment
次要结局
- The Number of Subjects Experiencing a Serious Adverse Event Through One Month Post Treatment.(Treatment through 1 month post procedure)
- Days of Convalescence Stay in an Intensive Care Unit(During the Index Hospitalization)
- Total Length of Hospital Stay (Days)(Total Duration of the Index Hospitalization)
- Time in Days to Return to Normal Daily Activities(Average time within one month window)
- Procedural Survival(Initial Device Implant Procedure During Index Hospitalization)
- Intensive Care Unit (ICU) Stay(Initial Device Implant Index Hospitalization)
- Procedure Time (Minutes)(Initial Device Implant Procedure During Index Hospitalization)
- Operative Blood Loss (mL)(Initial Device Implant Procedure During Index Hospitalization)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for Treatment of Acute Complicated Type B Aortic DissectionType B Aortic DissectionNCT00908388W.L.Gore & Associates50
已完成
2 期
GORE TAG® Thoracic Endoprosthesis - 45 mm for the Treatment of Aneurysms of the Descending Thoracic AortaAortic Aneurysm, ThoracicNCT00608829W.L.Gore & Associates23
进行中（未招募）
不适用
Evaluation of the GORE® TBE Device in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta, Zone 2Aortic Aneurysm, ThoracicLesion AortaNCT02777593W.L.Gore & Associates250
进行中（未招募）
不适用
Evaluation of the GORE® TBE Device in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta, Zone 0/1Aortic Aneurysm, ThoracicAorta, LesionNCT02777528W.L.Gore & Associates79
已完成
不适用
Early Feasibility of the Branched TAG® Device in the Treatment of Aortic Arch AneurysmsAneurysm of Aortic ArchNCT02264977W.L.Gore & Associates9