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临床试验/NCT05796986
NCT05796986招募中不适用

Endovascular Treatment of Wide Neck Saccular Cerebral Aneurysms

Sohag University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
efficacy of procedure

研究概览

简要总结

Intracranial aneurysm (IA) is a cerebrovascular disorder in which the weakness of a cerebral artery wall causes a localized dilation of the blood vessel. Intracranial aneurysm can develop and rupture, and about 85% of spontaneous subarachnoid hemorrhage (SAH) cases are caused by the rupture of Intracerebral aneurysm.

Two treatments are available globally: microsurgical clipping and endovascular treatment.

Endovascular treatment of Intracerebral aneurysms using detachable platinum coils ( was introduced in 1990 by Guido Guglielmi, an Italian neurosurgeon ) of different shapes and sizes are deposited into the aneurysm through a microcatheter, which reduces the blood flow and induces thrombus formation .

Wide neck aneurysm defined by neck diameter greater than 4 mm or dome-to-neck ratio less than 2 Despite advances in endovascular techniques , the treatment of wide-necked aneurysms remains problematic . Endovascular treatment of intracranial aneurysms is associated with lower morbidity and mortality rates and faster recovery compared with traditional microsurgical clipping.

In wide-necked Intracerebral aneurysms, complete coil embolization is often technically difficult owing to the risks of distal coil migration or coil impingement on the parent vessel .

Complete coil embolization using a single microcatheter without a supporting device in cases of wide-necked Intracerebral aneurysm is technically difficult. Total occlusion rates have increased recently as a result of the advancement of supporting devices These may include balloon remodeling, use of three-dimensional (3D) coils (Russian Doll Technique), combined use of stents and coils (Stent assisted coiling), flow diverters, use of intrasaccular flow disruption (like WEB), Double catheter Technique or combined extra- and intrasaccular devices.

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

性别
All
接受健康志愿者

入选标准

  • All patients of spontaneous subarachnoid haemorrhage due to ruptured wide neck saccular cerebral aneurysms
  • unruptured Denovo wide neck saccular cerebral aneurysms

排除标准

  • other forms of cerebral aneurysms rather than saccular type : fusiform and dissecting aneurysms
  • complex aneurysms : giant and thrombosed aneyrsms
  • any spontaneous subarachnoid haemorrhage with world fedriation of neurosurgery societies (WFNS) Grade 4&5
  • Any patient unfit for general anesethia or has serious renal impairment

结局指标

主要结局

efficacy of procedure

时间窗: 1 year

degree of aneurysm occlusion classifeid by Raymond Roy classification

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Ayman Mohamed

Assistant lecturer of neurosurgery

Sohag University

研究点 (1)

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