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Cerebral aneurysm / International Subarachnoid Aneurysm Trial / Subarachnoid hemorrhage / Aneurysm / Embolization / Coil / Clipping / Angiography / Endovascular surgery / Medicine / Neurosurgery / Endovascular coiling


Cerectye Coil Trial Cerecyte Coil Trial CLINICAL PROTOCOL
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Document Date: 2013-11-29 07:46:50


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City

Oxford / Cambridge / Toronto / Newcastle / /

Company

Cerecyte group Group / Micrus Endovascular Corporation / Boston Scientific / Micrus Endovascular UK Ltd / Data Monitoring Committee 9 Trial Executive Group / Micrus Corporation / /

Continent

North America / Europe / /

Country

United States / Canada / United Kingdom / /

Event

FDA Phase / /

Facility

Radcliffe Infirmary / University of Oxford / /

/

IndustryTerm

platinum coil technology / Stroke Prevention / coil devices / medical devices / secure web-based system / web-based clinical trials system / /

MedicalCondition

Large aneurysms / ruptured intracranial aneurysms / hydrocephalus / target aneurysm / aneurysm / Procedural aneurysm / endovascular aneurysm / intracranial aneurysm / Unruptured Aneurysms / significant aneurysm / further aneurysm / un-ruptured aneurysms / Disease / giant aneurysms / aneurysms / intracranial aneurysms / experimental aneurysms / cerebral aneurysms / /

MedicalTreatment

surgical treatment / surgery / /

Organization

U.K. Multi-centre Research Ethics Committee / NICE Interventional Procedures Committee / Institutional Review Board / Data Safety Monitoring Board / Core Lab. / Oxford Data Monitoring & Ethics Committee / University of Oxford / Cerectye Coil Trial Neurovascular Research Unit / Trial Steering Committee / Local Ethics Committee / U.S. Food and Drug Administration / European Union / Stroke Prevention Research Unit / Steering Committee / Neurovascular Research Unit / /

Person

Richard Kerr / Alan Fox / Peter Rothwell / Martin Jeffree / Julia Yarnold / Nicholas Higgins / Mary Sneade / Andrew Molyneux / Dennis Briley / David Mendelow / Statistical Methods (Appendix) / /

/

Position

Statistician / Consultant Neurologist & Senior Lecturer / full time coordinator / Trial Executive / Consultant Neurosurgeon / Newcastle / Trial Manager and Assistant Trial Manager / Consultant / Trial Coordinator and Trial Manager / and the Chief Investigator / Research nurse / Professor / co-principal Investigator / Consultant Neurosurgeon / Principal Investigator / centre investigator / Chair / Trial The Chief Investigator / DMEC Chairman / Chief Investigator / Consultant Neurologist / Oxford / Specialist registrar / Consultant Neurosurgeon / Consultant Neurologist / /

Product

OX2 / Matrix™ / If stent / United States / /

Technology

Alpha / existing platinum coil technology / MRI / platinum coil technology / /

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