jRCT2042230075进行中（未招募）不适用
TCD-12261 used for wide-necked ceberal aneurysm coil embolization : A multicenter, single arm study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 主要终点
- Coils remain inside the aneurysm
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 0month 0week old over 至 80age old under（—）
- 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.
结局指标
主要结局
Coils remain inside the aneurysm
Coils remain inside the aneurysm
Accuracy of placement to an aneurysm neck
Accuracy of placement to an aneurysm neck
Patency of the stent
Patency of the stent
No major adverse cerebrovascular event related to the procedure or device within 30 days after procedure
时间窗: 30 days after procedure
No major adverse cerebrovascular event related to the procedure or device
次要结局
未报告次要终点
研究者
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