JPRN-UMIN000008975已完成3 期
Clinical study of Wide-Necked Intracranial Artery Aneurysms using Self-Expanding Retrievable device System - TCD-11114 Clinical study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 33
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
- 20years-old 至 80years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •Exclusion Criteria; (1)Subject with Subarachnoid hemorrhage (SAH, ruptured cerebral aneurysm). (2)Subject who has an intracranial mass, abscess, or other agglomeration from an infection.Subject who is currently undergoing radiation therapy for carcinoma or sarcoma of the head or neck region. (3)Subject with dementia. (4) Subject with a history of bleeding diathesis, blood clotting defect, or with International Normalized Ratio (INR) >= 1.5, and or who refuses blood transfusion. (5) Subject with serum creatinine level > 2.0 mg/dL. (6)Subject with a life threatening allergy to contrast. (7)Subject with known allergies to nickel-titanium metal. (8) Subject with known allergies to aspirin, heparin, ticlopidine. (9)Subject who is expected to lives less than 6 months. (10)Subject who is currently participating in another clinical research study for medical devices and/or medicine. (11) Subject who placed a carotid stent for symptomatic hemodynamic derangement within 12 weeks. (12)Subject who has a known cardiac disorder, likely to be associated with cardioembolic symptoms such as AFIB (atrial fibrillation). (13)Subject who is in pregnancy or is suspected pregnancy. (14)Subject who has allergies or tolerance to aspirin and/or ticlopidine at preoperative antiplatelet therapy. Angiographic Exclusion Criteria; (15)Subject with a maximum diameter < 5 mm of aneurysm. (16)Subject with aneurysm arises from a parent vessel with a diameter of < 2.0 mm and > 4.5 mm. (17)Subject who judged that the target aneurysm is unsuitable for vascular treatment by angiography. (18)Subject has an arteriovenous malformation (AVM) in the territory of the target aneurysm. (19)Subject's aneurysm is expected to require more than one stent.
研究者
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