Condition category
Nervous System Diseases
Date applied
23/10/2000
Date assigned
23/10/2000
Last edited
11/03/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.surgery.ox.ac.uk/nvru/isat

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

http://www.oxfordradcliffe.nhs.uk/home.aspx

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Additional files

Editorial Notes