NCT01107366撤回4 期
Extensive Type A Dissections and Thoracic/ Thoraco-Abdominal
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- all cause mortality
研究概览
简要总结
To prospectively evaluate the safety and efficacy of the LUPIAE hybrid technique for the treatment of
- thoracic or thoraco-abdominal aortic aneurysms
- thoracic aortic type A dissections 2. to compare the safety and efficacy of the LUPIAE hybrid technique with historical groups (literature review, other hybrid techniques, LUPIAE retrospective patients)
详细描述
LUPIAE technique:
Hybrid repair of thoracic or thoraco-abdominal aneurysms of different etiology and type A dissections with a two-stage procedure:
- surgical arch reconstruction with a Dacron multibranched surgical prothesis
- endovascular implantation of a thoracic stent graft
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 willing to sign the informed consent, or In case of acute patients that should arrive at the hospital in unconsciousness status, patient's first degree relatives willingness to sign the informed consent and patient's willingness to re-consent for the study participation once he/she is again conscious.
- •Patients with extensive thoracic or thoraco-abdominal aortic aneurysms (>55 mm diameter), involving the ascending, arch and descending aortic segments, but not involving the renal arteries (at least 15 mm of healthy tissue above the most proximal renal artery).
- •Patients with extensive type A aortic dissection (DeBakey type I) with at least one of the following minimum criteria:
- •An initial false lumen diameter measured in the upper descending thoracic aorta >22 mm;
- •Total aortic diameter measured in the descending thoracic aorta >45 mm;
- •True lumen's compression (True lumen <10% of total aortic lumen);
- •Non-controlled hypertension;
- •Persistent pain;
- •Rupture or imminent rupture;
排除标准
- •Patient has a standard contraindication to the implant of thoracic stent graft;
- •Patient unable to commit to follow-up schedule;
- •Patient has medical conditions that preclude protocol required testing or limit study participation;
- •Patient is enrolled or intend to participate in another clinical trial during the course of this study;
- •Less than 18 years of age;
- •A life expectancy of less than one year, except for Patients with extensive type A aortic dissection (DeBakey type I)
结局指标
主要结局
all cause mortality
时间窗: 12 months
次要结局
未报告次要终点
研究者
研究点 (2)
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