JPRN-jRCT1090220242已完成1 期
Safety and efficacy of honeycomb microporous covered stent (NCVC-CS1) for the treatment of intracranial aneurysms: a multicenter, uncontrolled, exploratory trial - NCVC-CS1_UA
CVC-CS1 Clinical Trial Office0 个研究点目标入组 10 人开始时间: 2016年2月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
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 <= 75age old（—）
- 性别
- All
入选标准
- •(Provisional registration)
- •1. Age between 20 and 75 years old.
- •2. Target lesion is an unruptured aneurysm regardless of prior treatment diagnosed by angiography, CT angiography, or MR angiography within 180 days of provisional registration.
- •i) Target aneurysm located in petrous/cavernous portion of internal carotid artery, intradural vertebral artery except for its union, or basilar artery proximal to the orifice of superior cerebellar artery.
- •ii) Target aneurysm is considered difficult to treat by conventional surgical/endovascular procedures
- •iii) Target aneurysm with a sac diameter exceeding 7 mm.
- •iv) Target aneurysm with a neck diameter over 4 mm or with a ratio dome/neck smaller than 2.
- •3. Modified Rankin score of 3 or less
- •4. Agreement for participating in the study and informed consent signed by the patient.
- •(Proper registration)
- •1. Target lesion must be reconfirned by angiography or interventional procedure and is compatible with the conditions as follows:
- •i) Target aneurysm located in petrous/cavernous portion of internal carotid artery, intradural vertebral artry except for its union, or basilar artery below the orifice of superior cerebellar artery.
- •ii) Target aneurysm is considered difficult to treat by conventional surgical/endovascular procedures
- •iii) Target aneurysm with a sac diameter exceeding 7 mm.
- •iv) Target aneurysm with a neck diameter over 4 mm or with a ratio dome/neck smaller than 2.
- •v) Parent artery of target aneurysm is accessible by the investigational devices
- •vi) The diameter of the parent artery between 3.5 and 5 mm.
排除标准
- •(Provisional registration)
- •1. Any invasive surgical procedure within 30 days before registration.
- •2. Prior stent implantation at the site of target aneurysm
- •3. Existence of intracranial tumor, arteriovenous malformation for which any intervention is considered necessary, or co-existence of unruptured intracranial aneurysm whose sac diameter over 5mm within the target vessel.
- •4. Coexistence of other unruptured intracranial aneurysms which are planned for intervention
- •5. Target vessel not suitable for delivery and placement of covered stent because of anatomical configuration (i.e. severe bend or tortuosity).
- •6. More than 50% stenosis in the target vessel or its proximity including extracranial region.
- •7. Any intracranial hemorrhage within 42 days before registration.
- •8. Co-morbid conditions that may limit survival to less than 6 months, or difficult to observe the patient for 6 months.
- •9. Renal dysfunction whose serum creatinine more than 2.0
- •10. Contraindications to antiplatelet or anticoagulant treatment because of allergy or hemorrhagic diathesis.
- •11. Platelets less than 100,000/mm3 or known dysfunction of platelets.
- •12. Active bacterial infection.
- •13. Any cardiac, hematological, intracranial, or vessel disease which are considered to have high risk of neurological events (severe cardiac failure, atrial fibrillation, arteritis, known carotid artery stenosis, etc.).
- •14. History of severe allergy to contrast dye.
- •15. Known allergy to cobalt-chromium alloy and polyurethane. clopidogrel, heparin, nitinol, local or general anesthesia
- •16. Subjects who have enrolled, or are planned to participate in other clinical trial or intervention study.
- •17. Pregnant woman
- •18. Unsuitable patients judged by the physician attending this trial.
- •(Proper registration)
- •1. Hisutory of any invasive surgical procedure after the provisional registraton.
- •2. Any new neurological signs within 24 hours prior to the procedure.
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