Hydrocoil: Endovascular Aneurysm Occlusion and Packing Study

othian University Hospitals Division (UK)0 个研究点目标入组 500 人开始时间: 2005年4月1日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•Patient presenting with a cerebral aneurysm deemed to require endovascular treatment by the neurosurgeon/neurointerventionist (generically referred to subsequently as 'the neurovascular team'), and:
•1. Patient has given fully informed consent to endovascular coiling procedure
•2. Aneurysm 2 - 25 mm in maximum diameter
•3. Anatomy such that endovascular occlusion is deemed possible (not necessarily probable)
•4. The neurointerventionist is content to use either bare platinum or hydrocoil embolic system (HES) depending on randomisation result (i.e., clinical equipoise principle applies)
•5. The neurointerventionist is content not to use any other type of coated coil
•6. Patient World Federation of Neurological Surgeons (WFNS) Grade 0 - 2 and aged 18 - 75 years
•7. The patient has not been previously randomised into this trial
•8. Aneurysm has not previously been treated (by coiling or clipping)

•Subjects will not be considered for the trial unless they meet all the inclusion criteria. If the patient has more than one aneurysm requiring treatment at the same treatment episode they will not be eligible for the trial. If treatment will be staged in a patient with multiple aneurysms and only one aneurysm will be treated at one sitting then the patient is eligible. However, a patient may not be randomised into the study more than once.
•From the moment of randomisation, the patient is in the trial whether they receive trial treatment or not, and will be followed up and accounted for in the final analysis (intention-to-treat).
•Death or procedural/disease related morbidity may result in some subjects not having check angiography (or magnetic resonance angiography [MRA] if unit uses this as standard mode of follow-up). These patients will be counted as poor outcomes in the primary analysis.
•Retreatment of previously coiled or clipped aneurysm is an exclusion criteria.
•Use of coil assist devices (stent, balloon, trispan etc.) should be recorded but is not an exclusion criteria. It must be recorded in order to ascertain if any difference in use between control and hydrocoil groups acts as a potential confounding variable.

发起方

othian University Hospitals Division (UK)