Safety and Efficacy of Endovascular Coiling Using Target Tetra® Coils for Small Intracranial Aneurysm: Prospective, Open-label, Single Arm, Single Center Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Anerysm Occlusion Grade : 6 month Occlusion Grade
研究概览
简要总结
The goal of this study was to verify the safety and effectiveness of Target Tetra® Detachable Coil in the endovascular embolization treatment of small intracranial aneurysm (≤5mm).
详细描述
The study is a Prospective Single-arm Single-center Registry that aims to assess the safety and efficacy of the Target Tetra Coils in the endovascular treatment of small intracranial aneurysms (≤5mm). The study is not designed as intervention or treatment study. The investigators will enroll up to 100 participants at the single center.
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Enrollment of patients: The following process is carried out for patients who have consented to participate in the study among non-ruptured or ruptured cerebral aneurysm patients selected based on the inclusion and exclusion criteria.
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Before the procedure, the following items are verified:
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Informed consent form
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Demographic information
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Past medical history and family history
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Vital signs
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Electrocardiogram (ECG) results (results from within the previous 12 weeks before the screening visit can be used)
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Laboratory test results (results from within the previous 12 weeks before the screening visit can be used): WBC, RBC, Hb, Hct, platelet count, PT INR, aPTT, cholesterol, ALP, AST, ALT, albumin, total bilirubin, total protein, BUN, creatinine, eGFR*, Urine-HCG†, FBS, triglycerides, LDL, PRU (VerifyNow test), and ARU (VerifyNow test) *eGFR = (140 - age) x (weight/72) x Creatinine
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Pregnancy test (if applicable)
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Imaging findings (results from within the previous 1 year before the screening visit can be used)
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Adverse events
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Concomitant medications/therapies
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Pre-procedure modified Rankin Scale (mRS) assessment
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 19 to 80 years
- •Patients with intracranial aneurysms suitable for endovascular embolization therapy with a maximum diameter of 5mm or less
- •Including both ruptured and unruptured intracranial aneurysms
- •Patients for whom the use of Target Tetra® coil is expected in endovascular coil embolization therapy
- •Patients who have undergone balloon-assisted coiling or adjunctive stent placement during coil embolization
- •Subjects who have received an explanation of the clinical study and provided written consent to participate in the study
排除标准
- •Age below 18 or above 81 years
- •Infectious, dissecting, traumatic, or mycotic aneurysms
- •Patients who have undergone surgical or endovascular treatment for the target intracranial aneurysm
- •Patients in whom vascular access to the target intracranial aneurysm is not possible due to conditions such as moyamoya disease, dural arteriovenous malformation, significant atherosclerotic stenosis, or severe vessel tortuosity
- •Patients with ruptured intracranial aneurysms classified as Hunt and Hess grade 5 (deep coma)
- •Patients with hypersensitivity reactions to the materials used in the coils, such as platinum, tungsten, nickel, or stainless steel
- •Patients with serious adverse reactions to contrast agents
- •Patients who are unable to complete planned follow-up observations due to expected short-term survival or comorbidities
- •Female patients who are pregnant (positive pregnancy test) or planning pregnancy within 12 months after coil placement, or breastfeeding
- •Patients with significant renal dysfunction or uncorrected coagulation disorders
结局指标
主要结局
Anerysm Occlusion Grade : 6 month Occlusion Grade
时间窗: 6 months(±30 days) from procedure date
Aneurysm Packing Density : Packing Density
时间窗: Procedure day
Anerysm Occlusion Grade : 12 month Occulsion Grade
时间窗: 12 months(±30 days) from procedure date
Anerysm Occlusion Grade : Procedure day Occlusion Grade
时间窗: Procedure day
次要结局
- Non-neurological complications(Procedure, 1 month from procedure date)
- Neurological complications(Procedure, 1 month from procedure date)
- Device-related events(procedure date)
- Clinical outcomes(Procedure, 1 month, 6 months, 12 months from procedure date)
- Incidence of recurrence and retreatment(Procedure, 6 months, 12 months from procedure date)