NCT01033214Unknown1 期
A Phase I Feasibility Study of the TAArget Thoracic Stent Graft for the Treatment of Aneurysms in the Descending Thoracic Aorta
Duke Vascular, Inc.4 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2010年1月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- The primary effectiveness endpoint of early (30-day) and late (6-month) endovascular TAA repair will be assessed by the proportion of subjects free from major device related events
研究概览
简要总结
Evaluate the safety and effectiveness of endovascular repair with the LeMaitre TAArget thoracic stent graft as an alternative to open surgical repair.
详细描述
- Subject is > 18 years of age.
- Females subjects must be either documented post-menopausal, surgically incapable of bearing children, or for women of childbearing potential, using barrier contraceptive methods and must have a negative serum pregnancy test at screening.
- Subject is a candidate for endovascular thoracic aortic repair.
- Subject has a TAA that meets one of the following criteria:
- Is diagnosed with a Fusiform Focal TAA >5cm, or
- Is diagnosed with a Fusiform Focal TAA that has a diameter < 5 cm and has exhibited rapid expansion, or
- Is diagnosed with a Fusiform Focal TAA that has a diameter ≥ 4.5 cm and is at least twice the size of the normal DTA, or
- Is diagnosed with a saccular TAA of any size.
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 is > 18 years of age. Female subjects are either documented post-menopausal, surgically incapable of bearing children, or for women of childbearing potential, using barrier contraceptive methods and have a negative serum pregnancy test at screening.
- •Subject is a candidate for endovascular thoracic aortic repair.
- •Subject has a TAA that meets one of the following criteria:
- •Is diagnosed with a Fusiform Focal TAA ≥5cm, or
- •Is diagnosed with a Fusiform Focal TAA that has a diameter ≤ 5 cm and has exhibited rapid expansion, or
- •Is diagnosed with a Fusiform Focal TAA that has a diameter ≥ 4.5 cm and is at least twice the size of the normal DTA, or
- •Is diagnosed with a saccular TAA of any size (where potential for rupture is increased*).
- •Tortuosity and angulation do not exceed 90 degrees.
- •Subject has an arterial access site that allows for the introduction of the stent-graft delivery system.
排除标准
- •Subject has a life expectancy < 2 years.
- •Subject has a lesion that prevents safe delivery or expansion of the device.
- •Subject has concomitant ascending aortic aneurysm.
- •Subject has known allergies to any of the device materials.
- •Subject has coagulopathy or bleeding disorders that cannot be pre-treated.
- •Subject is contraindicated for contrast medium and anticoagulation drugs that cannot be pre-treated.
结局指标
主要结局
The primary effectiveness endpoint of early (30-day) and late (6-month) endovascular TAA repair will be assessed by the proportion of subjects free from major device related events
时间窗: 30 day and 6 months
Proportion of subjects who experience ≥ 1 major adverse events (MAE) related to the experimental device/procedure at early (30-day) and late (6-month) endovascular TAA repair as compared with the open surgical repair group.
时间窗: 30 day and 6 month
次要结局
- • All cause mortality • Aneurysm related mortality compared to an open surgical control group • Major adverse events • Minor adverse events(30 day and 6 month)
研究者
研究点 (4)
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