JPRN-jRCT2092220032已完成3 期
A Clinical Study Evaluating the Safety and Efficacy of BS054 Combined with Coil Embolization as a Treatment of Unruptured Wide Neck Intracranial Aneurysm - BS054
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
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
- >= 20age old 至 <= 80age old(—)
- 性别
- All
入选标准
- •1)Unruptured wide neck intracranial aneurysm
- •2)The parent artery diameter within the range of 2.0 to 4.5 mm.
- •3)The target intracranial aneurysm is difficult to be treated by surgery and coil embolization with the use of embolization coils alone.
排除标准
- •1)The target intracranial aneurysm has a history of rupture.
- •2)Stent implantation in the neck or cranium within 4 weeks before the study procedure.
- •3)Two or more untreated intracranial aneurysms with the maximum diameters of >= 10 mm.
- •4)The access of the Stent to the target intracranial aneurysm is considered impossible anatomically or procedurally by angiography, or the access to the intracranial aneurysm is impossible because of severe vasospasm refractory to medications.
- •5)The patient has hemorrhagic diathesis.
- •6)Antiplatelet/anticoagulation therapy is contraindicated.
- •7)The patient has a complication of a disease condition causing cardiogenic cerebral infarction.
- •8)Renal failure (serum creatinine >= 2.0 mg/dL).
研究者
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