JPRN-jRCT2042230075招募中3 期
TCD-12261 used for wide-necked ceberal aneurysm coil embolization : A multicenter, single arm study
Chiaki Chiba0 个研究点目标入组 40 人开始时间: 2023年9月5日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
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 <= 80age old（—）
- 性别
- All
入选标准
- •Subjects must meet the following criteria to be included in the study:
- •(1)Uunruptured, wide-necked (neck => 4mm or dome/neck ratio <2) intracranial, a diameter => 5 mm aneurysm, the parent artery is 2.0 - 4.0 mm.
- •(2)Difficult to treat with surgery or only embolization coils.
- •(3)Age is >= 18, =< 80 years at the time of informed consent.
- •(4)Patients understand the purpose and contents and then provide a signed informed consent form by his/her own will.
- •(5)follwing the rules, of this trial such as trial visit scedules, examinations.
排除标准
- •At pre-registraton, patients will be excluded from the study for:
- •(1)Having intracranial masses such as tumors, abscesses, or other infections. Undergoing radiation therapy for head or neck tumors or sarcomas.
- •(2)History of bleeding diathesis, abnormal coagulation. Refusing a blood transfusion.
- •(3)Drugs required for EVT are contraindicated. Having allergies of acontrast agents. Needed Usage restrictions of acontrast agents.
- •(4)Hypersensitivity to metal, such as nickel-titanium and metal jewelry
- •(5)Life expectancy less than 6 months.
- •(6)Current participation in clinical study that has not completed primary endpoint evaluation or studies that may have an impact on the evaluation of this clinical trial.
- •(7)Have/will receive treatments that may have an impact on the evaluation of this clinil trial within 3 months prior to TCD-12261 surgery.
- •(8)History of heart disease or complication highly relevant to atrial fibrillation and cardiogenic embolism.
- •(9)Active bacterial infections.
- •(10)Pre-existing stents in place at the target aneurysm.
- •(11)Currently pregnant, planning to become pregnant during the course of the study.
- •(12)Considered ineligible for the study by the investigator.
- •At registraton, patients will be excluded from the study for:
- •(13)Uunruptured, wide-necked (neck < 4mm or dome/neck ratio >2) intracranial, a diameter < 5 mm aneurysm, the parent artery < 2.0mm or > 4.0 mm.
- •(14)Considered ineligible for the EVT treatment by the investigator.
- •(15)Ipsilateral arteriovenous malformations.
- •(16)Having other aneurysms needed to treat during the course of the study.
- •(17)Needed 2 or more stents to treat target aneurysm.
研究者
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