Treatment of Intracranial Aneurysms using a vascular Reconstruction Assist device: a randomised controlled trial of self expanding stent (conventional mesh density) plus coiling versus coiling +/- temporary assist techniques

othian University Hospitals Division (UK)0 个研究点目标入组 550 人开始时间: 2011年4月7日最近更新: 2016年10月17日

适应症

试验速览

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•1. Age range 18-70 (evidence that procedural risk for stent placement in over 70 is 4 fold greater and saccular aneurysms are extremely uncommon under 18)
•2. Patient world federation of neurosurgeons (WFNS) Grade 0-2 [anticipated most patients recruited will be 0]
•3. Aneurysm judged suitable for treatment by coiling plus or minus the stent assistance and operator content to use/not use stent according to randomisation treatment allocation result
•4. Aneurysm greater than or equal to 8mm in maximal diameter, with aneurysm neck greater than 4mm or dome to neck ratio less than 2:1, but less than 25mm in size. If target aneurysm previously treated by coiling the recurrence must have a maximal diameter in this range
•5. If a patient presents with subarachnoid haemorrhage (SAH) and staged treatment with delayed stenting is judged appropriate due to aneurysm size/neck width then the patient is eligible

•1. Does not meet aneurysm size/neck characteristics outlined in inclusion criteria
•2. Less than18 years or more than 70 years of age
•3. Pregnant
•4. Unable to consent for themselves
•5. Non-saccular aneurysm - e.g. blister, fusiform or definitely dissecting aneurysm
•6. Subarachnoid hemorrhage (SAH)/intracerebral haemorrhage from another aneurysm or intracranial lesion within last 28 days
•7. Major surgery within last 30 days (or any other medical situation where dual antiplatelet therapy is contraindicated in the opinion of the responsible neurovascular team)
•8. Intention to deploy flow diverting device/construct as primary aneurysm treatment
•9. More than one aneurysm requiring treatment in current procedure
•10. Target or a nearby aneurysm has had previous stent treatment such that a Vascular Reconstruction Device [VRD i.e. a stent] is already across all or greater than 1/3 of the neck of the target aneurysm
•11. Medical or surgical co-morbidity such that the patient?s life expectancy is less than 1 year
•12. The patient has been previously randomised into this trial
•13. Patient has been randomised into another trial of an endovascular device for aneurysm treatment within the last 6 months
•14. Deployment of stent judged essential to treat the aneurysm

发起方

othian University Hospitals Division (UK)