NCT00803075已完成4 期
TALENT Endoluminal Stent Graft System for the Treatment of Abdominal Aortic Aneurysms
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- Vessel perforation
研究概览
简要总结
The purpose of this study is to determine if it is safe and effective to use the TALENT AAA Stent Graft System as a treatment for AAAs in patients who are also candidates for conventional surgical aneurysm repair.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Patient has one of the following:
- •Aneurysm >4 cm in diameter, or an aneurysm that has increased in size by 0.5 cm in the last 6-months
- •Aneurysm is 1.5 times larger than the diameter of the normal infrarenal aorta or symptomatic
- •Aneurysm is saccular
- •Penetrating ulcer
- •Patient's vascular dimensions must be in the range that can be safely treated with the stent graft available to the physician at the time of the procedure.
- •Patient has endovascular access to the aneurysmal site with the Introducer Sheath or Delivery Catheter of the appropriate ize device chosen for treatment.
- •Patient has anatomic characteristics suitable for endovascular repair.
- •Patient has an immediate life-threatening disease of the abdominal aorta in which there is a reasonable likelihood that death will occur within a matter of months or in which premature death is likely without early treatment.
- •Patient is American Society of Anesthesiology (ASA) grade 1 through
- •Patient is able and willing to comply with 3 month, 6 month, 1 year and every year thereafter post treatment follow-up requirements.
- •Patient or patient's legal representative understands and has signed an Informed Consent.

排除标准
- •Patient is pregnant or nursing.
- •Patient is morbidly obese or has other clinical conditions that severely inhibit X-ray visualization of the aorta.
- •Patient has connective disease.
- •Patient is hypercoagulable.
- •Patient has active systemic infection.
- •Patient is less than 18 years old.
- •Patient has less than a one-year life expectancy.
- •Patient is unwilling or unable to return for follow-up visits.
结局指标
主要结局
Vessel perforation
Major morbidity and mortality
Deployment success
Aneurysm rupture
Delivery success
Stent graft migration
Aneurysm exclusion
Stent graft occlusion
Stent graft patency
Device integrity
Collateral vessel occlusion
次要结局
- Patency
- Technical success
研究者
研究点 (2)
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