NCT02907229已完成不适用
Safety and Efficacy of Honeycomb Microporous Covered Stents (NCVC-CS1) for the Treatment of Intracranial Aneurysms: a Multicenter, Uncontrolled, Exploratory Trial
National Cerebral and Cardiovascular Center, Japan4 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2016年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Efficacy evaluation: Complete obliteration of target aneurysm and patency of target vessel (less than 50% stenosis) confirmed by angiography at 180 days after the procedure
研究概览
简要总结
This trial is conducted to evaluate the safety and technical effectiveness of using NCVC-CS1, a newly developed honeycomb microporous covered stent, for the treatment of intracranial aneurysms which are difficult to be cured by conventional surgical or endovascular procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(Provisional registration)
- •Age between 20 and 75 years.
- •Target lesion is an unruptured aneurysm regardless of prior treatment diagnosed by angiography, CTA, or MRA within 180 days
- •Target aneurysm located in petrous/cavernous portion of internal carotid artery, intradural vertebral artery except for its union, or basilar artery below the orifice of superior cerebellar artery.
- •Target aneurysm is considered difficult to treat by conventional surgical/endovascular procedures
- •Target aneurysm with a sac diameter exceeding 7 mm.
- •Target aneurysm with a neck diameter over 4 mm or with a ratio "dome/neck" smaller than
- •Modified Rankin score of 3 or less
- •Agreement for participating in the study and informed consent signed by the patient.
- •(definitive registration)
- •Target lesion must be reconfirmed by angiography or interventional procedure and is compatible with the conditions as follows:
- •Target aneurysm located in petrous/cavernous portion of internal carotid artery, intradural vertebral artery except for its union, or basilar artery below the orifice of superior cerebellar artery.
- •Target aneurysm is considered difficult to treat by conventional surgical/endovascular procedures
- •Target aneurysm with a sac diameter exceeding 7 mm.
- •Target aneurysm with a neck diameter over 4 mm or with a ratio "dome/neck" smaller than
- •Parent artery of target aneurysm is accessible by the investigational devices
- •The diameter of the parent artery between 3.5 and 5 mm.
排除标准
- •(Provisional registration)
- •Any invasive surgical procedure within 30 days before registration.
- •Prior stent implantation at the site of target aneurysm
- •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.
- •Coexistence of other unruptured intracranial aneurysms which are planned for intervention
- •Target vessel not suitable for delivery and placement of covered stent because of anatomical configuration (i.e. severe bend or tortuosity).
- •More than 50% stenosis in the target vessel or its proximity including extracranial region.
- •Any intracranial hemorrhage within 42 days before registration.
- •Co-morbid conditions that may limit survival to less than 6 months, or difficult to observe the patient for 6 months.
- •Renal dysfunction whose serum creatinine more than 2.0
- •Contraindications to antiplatelet or anticoagulant treatment because of allergy or hemorrhagic diathesis.
- •Platelets less than 100,000/mm3 or known dysfunction of platelets.
- •Active bacterial infection.
- •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.).
- •History of severe allergy to contrast dye.
- •Known allergy to cobalt-chromium alloy and polyurethane. clopidogrel, heparin, nitinol, local or general anesthesia
- •Subjects who have enrolled, or are planned to participate in other clinical trial or intervention study.
- •Pregnant woman
- •Unsuitable patients judged by the physician attending this trial.
- •(definitive registration)
- •History of any invasive surgical procedure after the provisional registration.
- •Any new neurological signs within 24 hours prior to the procedure.
研究组 & 干预措施
Treatment group
Experimental
neuroendovascular therapy(NCVC-CS1)
干预措施: NCVC-CS1 (Device)
结局指标
主要结局
Efficacy evaluation: Complete obliteration of target aneurysm and patency of target vessel (less than 50% stenosis) confirmed by angiography at 180 days after the procedure
时间窗: 180 days after the procedure
Safety evaluation: Any stroke or death related to the procedure within 180 days
时间窗: 180 days after the procedure
次要结局
- Neurological assessment (scale ; Barthel Index)(180 days after the procedure)
- Technical success (stent placement in the target lesion covering aneurysmal neck without occlusion of target vessel)(180 days after the procedure)
- Any death within 180 days after the procedure(180 days after the procedure)
- Any death by neurological reason within 180 days after the procedure(180 days after the procedure)
- Any adverse event or adverse device effect(180 days after the procedure)
- Neurological assessment (scale ; mRS)(180 days after the procedure)
- Neurological assessment (scale ; NIHSS)(30 days after the procedure)
- Neurological assessment (scale ; GCS)(30 days after the procedure)
研究者
Tetsu Satow
Senior staff
National Cerebral and Cardiovascular Center, Japan
研究点 (4)
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