jRCT2052230047暂停不适用
Thoracic Stent-Graft System TCD-11226; A non-blind multicenter clinical trial
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 42
- 主要终点
- Effectiveness endpoint
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Age is >= 18 years at the time of informed consent.
- •Patients considered suitable for TEVAR using thoracic stent-graft system TCD-11226 after comprehensive evaluation of risk factors and consideration of other treatment options.
- •Patients with a minimum inner diameter of the central landing zone of the TCD-11226 main stent-graft of 28 mm or larger.
- •Patients with no dissection in BCT and LCCA, which are landing zones of the TCD-11226 branch stent-graft.
- •Patients with femoral/iliac artery diameter accessible with 25 Fr delivery catheter.
排除标准
- •Patients with inaccessible access from the femoral or iliac artery.
- •Patients with difficult-to-pass stenosis or Grade 2 or higher atherosclerotic thrombosis in the TCD-11226 branch stent-graft device approach vessel.
- •Patients with Grade 2 or higher atherosclerotic thrombosis at the landing zone of the TCD-11226 branch stent-graft.
- •Patients who have had symptomatic stroke or cerebral hemorrhage within 6 months prior to trial registration.
- •Patients who have participated in another clinical trial of a pharmaceutical product or medical device within 1 year prior to trial registration.
结局指标
主要结局
Effectiveness endpoint
时间窗: 1 year after treatment
Percentage of subjects achieving all of the following four items up to 1 year after treatment: 1. No occurrence of stent-graft migration (>=10 mm) 2. No occurrence of complete occlusion of branch stent-grafts 3. No secondary therapeutic intervention for Type I or Type III endoleaks 4. No occurrence of death due to aortic rupture at the treatment site
Safety endpoint
时间窗: 30 days after treatment
Percentage of subjects with any of the following six events within 30 days after treatment (6 judged on the day of treatment): 1. All-cause mortality 2. Stroke 3. Paraplegia/Paraparesis 4. New post-treatment dialysis 5. Aortic rupture at the treatment site 6. Unsuccessful device placement
次要结局
未报告次要终点
研究者
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