Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Andrew J Molyneux
ORCID ID
Contact details
Oxford Neurovascular & Neuroradiology Research Unit (ONNRU)
West Wing
Level 6
John Radcliffe Hospital
Headley Way
Oxford
OX3 9DU
United Kingdom
+44 (0)1865 234755
andy.molyneux@nds.ox.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G9401611
Study information
Scientific title
International Subarachnoid Aneurysm Trial
Acronym
ISAT
Study hypothesis
To compare the safety and efficacy of an endovascular treatment policy of ruptured intracranial aneurysms with a conventional neurosurgical treatment policy in an eligible population.
Primary objective: To determine whether an endovascular treatment policy of acutely ruptured intracranial aneurysms compared with a neurosurgical treatment policy, reduces the proportion of patients with a moderate or poor outcome (defined by Rankin grade 3-6 ) by 25% at one year.
Secondary objectives: To determine if:
1. This is as effective as neurosurgery in preventing re-bleeding from the treated aneurysm including long-term follow up
2. This results in a better quality of life than neurosurgery at one year (Euroquol measure)
3. This is more cost effective than neurosurgical treatment
4. This improves the neuropsychological outcome at one year (selected centres only)
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Neuroscience, psychiatry
Intervention
1. Endovascular treatment policy of ruptured intracranial aneurysms
2. A conventional neurosurgical treatment policy
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
Modified Ranking scale, Glasgow outcome scale, Neuropsychology assessment in some centres. Euroquol quality of life assessment, health economic evaluation including back to work rates
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1997
Overall trial end date
31/12/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Proven subarachnoid haemorrhage (SAH) on Computed Tomography (CT) or lumbar puncture
2. Presence of an intracranial aneurysm demonstrated by intra-arterial angiography likely to be responsible for the SAH
3. The patient in a clinical state that justifies treatment at some time by either surgical or endovascular means
4. Intracranial aneurysm judged to be suitable for either technique based on its angiographic anatomy and the responsible clinician is uncertain which is the best method of treatment
5. Appropriate consent of the patient or relatives
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
2143
Participant exclusion criteria
1. More than 28 days from SAH, unproven SAH
2. Unsuitable for both treatments
3. Refusal of consent
4. Patient participating in another trial
Recruitment start date
01/01/1997
Recruitment end date
31/12/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Oxford Neurovascular & Neuroradiology Research Unit (ONNRU)
Oxford
OX3 9DU
United Kingdom
Sponsor information
Organisation
Oxford Radcliffe Hospital NHS Trust (UK)
Sponsor details
John Radcliffe Hospital
Headley Way
Oxford
OX3 9DU
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2005 results in: http://www.ncbi.nlm.nih.gov/pubmed/16139655
2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20616321
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21819189
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25465111
Publication citations
-
Results
Molyneux AJ, Kerr RS, Yu LM, Clarke M, Sneade M, Yarnold JA, Sandercock P, , International subarachnoid aneurysm trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomised comparison of effects on survival, dependency, seizures, rebleeding, subgroups, and aneurysm occlusion., Lancet, 366, 9488, 809-817, doi: 10.1016/S0140-6736(05)67214-5.
-
Results
Hart Y, Sneade M, Birks J, Rischmiller J, Kerr R, Molyneux A, Epilepsy after subarachnoid hemorrhage: the frequency of seizures after clip occlusion or coil embolization of a ruptured cerebral aneurysm: results from the International Subarachnoid Aneurysm Trial., J. Neurosurg., 2011, 115, 6, 1159-1168, doi: 10.3171/2011.6.JNS101836.
-
Scott RB, Eccles F, Molyneux AJ, Kerr RS, Rothwell PM, Carpenter K, Improved cognitive outcomes with endovascular coiling of ruptured intracranial aneurysms: neuropsychological outcomes from the International Subarachnoid Aneurysm Trial (ISAT)., Stroke, 2010, 41, 8, 1743-1747, doi: 10.1161/STROKEAHA.110.585240.
-
Results
Molyneux AJ, Birks J, Clarke A, Sneade M, Kerr RS, The durability of endovascular coiling versus neurosurgical clipping of ruptured cerebral aneurysms: 18 year follow-up of the UK cohort of the International Subarachnoid Aneurysm Trial (ISAT), Lancet, 2015 , 385, 9969, 691-697, doi: 10.1016/S0140-6736(14)60975-2.