JPRN-jRCT2052230047暂停3 期
Thoracic Stent-Graft System TCD-11226; A non-blind multicenter clinical trial
Sugisaki Shunichiro0 个研究点目标入组 42 人开始时间: 2023年6月21日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 发起方
- 入组人数
- 42
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Age is >= 18 years at the time of informed consent.
- •2. Patients considered suitable for TEVAR using thoracic stent-graft system TCD-11226 after comprehensive evaluation of risk factors and consideration of other treatment options.
- •3. Patients with a minimum inner diameter of the central landing zone of the TCD-11226 main stent-graft of 28 mm or larger.
- •4. Patients with no dissection in BCT and LCCA, which are landing zones of the TCD-11226 branch stent-graft.
- •5. Patients with femoral/iliac artery diameter accessible with 25 Fr delivery catheter.
排除标准
- •1. Patients with inaccessible access from the femoral or iliac artery.
- •2. Patients with difficult-to-pass stenosis or Grade 2 or higher atherosclerotic thrombosis in the TCD-11226 branch stent-graft device approach vessel.
- •3. Patients with Grade 2 or higher atherosclerotic thrombosis at the landing zone of the TCD-11226 branch stent-graft.
- •4. Patients who have had symptomatic stroke or cerebral hemorrhage within 6 months prior to trial registration.
- •5. Patients who have participated in another clinical trial of a pharmaceutical product or medical device within 1 year prior to trial registration.
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