Zenith® TX2® Low Profile TAA Endovascular Graft Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 59
- 主要终点
- Patients With Major Adverse Events (MAE)
研究概览
简要总结
The Zenith® TX2® Low Profile TAA Endovascular Graft study is a clinical trial approved by US FDA to evaluate the safety and effectiveness of the Zenith® TX2® Low Profile TAA Endovascular Graft indicated for the treatment of patients with aneurysms/ulcers of the descending thoracic aorta having vessel structure suitable for repair.
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
- •Descending thoracic aneurysm with diameter ≥ 5.0 cm
- •Descending thoracic aneurysm with a history of growth ≥ 0.5 cm per year
- •Descending thoracic degenerative or atherosclerotic ulcer ≥ 10 mm in depth and 20 mm in diameter
排除标准
- •Less than 18 years of age
- •Life expectancy less than 2 years
- •Pregnant or breastfeeding or planning on becoming pregnant within 60 months
- •Unwilling to comply with the follow-up schedule
- •Inability or refusal to give informed consent
- •Less than 30 days beyond primary endpoint for other investigative drug or device study
结局指标
主要结局
Patients With Major Adverse Events (MAE)
时间窗: 30 days
Major adverse event is defined as: All-cause death; Q-wave MI; cardiac event involving arrest, resuscitation, or balloon pump; ventilation \> 72 hours or re-intubation; pulmonary event requiring tracheostomy or chest tube; renal failure requiring permanent dialysis, hemofiltration, or kidney transplant in a patient with a normal pre-procedure serum creatinine level; bowel resection; stroke; paralysis; amputation involving more than toes; aneurysm or vessel leak requiring re-operation; deep vein thrombosis requiring surgical or lytic therapy; pulmonary embolism involving hemodynamic instability or surgery; coagulopathy requiring surgery; or wound complication requiring return to the operating room.
Patients With Device Failures
时间窗: 12 months
Device failure is defined as: Technical failure (inability to access or deploy the Zenith® TX2® Low Profile TAA Endovascular Graft or loss of patency at the time of deployment completion), or any of the following: type I or type III endoleaks requiring re-intervention, aneurysm rupture or conversion to open surgical repair, aneurysm enlargement greater than 0.5 cm.
次要结局
未报告次要终点