Prospective, Randomized, Controlled, Open Label, All China, Multi-Center, Registration Trial of the MICROPORT NEUROTECH Coil Embolization System for the Traetment of Intracranial Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 334
- 试验地点
- 1
- 主要终点
- Raymond Scale
研究概览
简要总结
The scope of this trial is the collection and analysis of effectiveness and safety endpoints, related to the use of the MicroPort NeuroTech Coil Embolization System in the treatment of intracranial aneurysms.
详细描述
A cerebral aneurysm (also known as an intracranial or intracerebral aneurysm) is a weak or thin spot on a blood vessel in the brain that balloons out and fills and intermixes with parent artery blood. Aneurysms can occur at any age. Global incidence varies by country, with reports of prevalence ranging from 5.1 to 19.6 cases per 100,000 persons. With the development of imaging technology and the greater attention paid by people to their overall health,there will be more aneurysms be detected. The combination of sophisticated imaging equipment, more frequent use of imaging in patients, and the aforementioned emphasis on optimum health, has led to a greater proportion of asymptomatic aneurysms being discovered.
The most common type of aneurysms are saccular; and, aneurysms are more likely to occur in women. The most devastating presentation of an intracranial aneurysm is subarachnoid hemorrhage (SAH). It is estimated that, on average, five percent of the population is afflicted and the incidence of aneurysm rupture (SAH) is between 6 and 9 per 1000 000 individuals . Mortality can approach 50%, with fewer than 60% of survivors returning to independent living.
Invasive treatment of aneurysms began with an open surgical procedure referred to as 'surgical clipping'. This treatment was once considered the gold standard treatment for aneurysms. The first neurovascular interventional medical device was the Guglielmi Detachable Coil (GDC), which was developed and tested in the mid-1990s and was introduced by Dr. Guido Guglielmi and Target Therapeutics, Fremont, California. These bare platinum coils were electrolytically detached for placement in the aneurysm sac. It took approximately one decade to prove coiling superiority over surgical clipping, after publication of the results of the ISAT Study. Since that time, coils have become more sophisticated in makeup and conformation. Coil use is also a mainstay for neurovascular procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥18 years old and ≤80 years old at the time of signing the informed consent;
- •Intracranial ruptured or unruptured, single, previously untreated, saccular aneurysm diagnosed by CTA, MRA, DSA or other similar neuroimaging examination;
- •The maximum diameter of target aneurysm ≤24mm;
- •Baseline modified Rankin score (mRS) ≤2 points;
- •Baseline Hunt - Hess scores of patients with ruptured aneurysm ≤ Ⅲ;
- •The target aneurysm can be embolized in one operation;
- •The patient or the patient's guardian signs the informed consent voluntarily and is willing to accept follow-up.
排除标准
- •Clear allergy, resistance or contraindication to antiplatelet drugs, anticoagulants, contrast agents and/or anesthetics.
- •Definite allergy to platinum, tungsten and/or any substances of coils.
- •Subjects who are not suitable for anesthesia or endovascular treatment, such as those suffering from severe respiratory system, liver and kidney diseases or coagulation disorders (such as hemophilia).
- •Target aneurysm parent vessel stenosis ≥70%.
- •Anatomy not appropriate for endovascular treatment due to severe intracranial vessel tortuosity or stenosis, or intracranial vasospasm not responsive to medical therapy.
- •The target aneurysm has previously received surgery or other endovascular treatment.
- •Ruptured aneurysm requiring stent-assisted embolization.
- •The target aneurysm is hemangioid aneurysm, dissected aneurysm, fusiform aneurysm, infectious aneurysm, pseudoaneurysm, or arteriovenous malformation, or aneurysm associated with Moyamoya disease.
- •Major surgery was performed within 30 days before enrollment, or surgery was planned within 90 days after enrollment.
- •Patients with active infection at puncture point or other serious infection are not suitable for endovascular treatment.
- •Illness with a potential risk of sudden death.
- •Subjects with intracranial space-occupying lesions (e.g., intracranial tumor, abscess, etc.) or who are receiving radiotherapy for their head and neck.
- •Long-term treatment with anticoagulant drugs (such as warfarin) is required.
- •Having cognitive impairment, psychiatric disorder or other medical condition that may affect the data evaluation or trial results.
- •Unable to understand the trial or has a record of noncompliance with medical advice.
- •Taking banned medicine.
- •Life expectancy less than 1 year, may not complete follow-up.
- •Women in pregnancy or lactation, or women with positive pregnancy test.
- •Subjects who are participating in clinical trials of other drugs or devices and have not reached the end point of the trial, or are expected to participate in clinical trials of other drugs or devices.
- •Investigators do not consider it appropriate to participate in this study.
结局指标
主要结局
Raymond Scale
时间窗: 6 Months
For the MicroPort NeuroTech Coil Embolization System, this endpoint will be based upon the 6-month Core Lab identification of patients with "Successful occlusion" rate: % of subjects who at 6 months' post coiling, reported as a combination of Raymond 1 and Raymond 2 outcomes (95%-100%). The endpoint will be expressed as a percentage of all evaluable subjects with complete and nearly complete (95%-100%) occlusion in the context of the whole population of evaluable subjects (n/N).
次要结局
- Modified Rankin Scale(6 Months)