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Interv Neuroradiol. 2004 Jun 29;10(2):103-12. Epub 2004 Oct 22.

A randomized trial on the safety and efficacy of endovascular treatment of unruptured intracranial aneurysms is feasible.

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  • 1CHUM Notre-Dame Hospital, Radiology department, Université de Montréal; Montréal, Quebec, Canada - dr_jean_raymond@hotmail.com.

Abstract

SUMMARY:

The safety and efficacy of endovascular treatment of unruptured intracranial aneurysms remain undetermined. A randomized trial may be the best way to demonstrate the potential benefits of endovascular management. We propose a randomized, prospective, controlled trial comparing the incidence of subarachnoid haemorrage of patients treated by endovascular coiling as compared to conservative management. We would also study a composite outcome combining SAH and the morbidity of treatment. All patients with one or more unruptured aneurysm >> 3 mm eligible for endovascular treatment would be proposed to participate. The study would be conducted in 40-50 centres. The entire study would enrol 1800 patients, recruited over three years and followed for five years, but would be preceded by a feasibility study on 200 patients. A randomized trial comparing endovascular and conservative treatment could have an important impact on the clinical management of intracranial aneurysms.

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