Evidence map›Paper›PMID 23714335›Full record

Trial reportTrials2013

International Subarachnoid Aneurysm Trial - ISAT part II: study protocol for a randomized controlled trial.

Tim E Darsaut, Andrew S Jack, Richard S Kerr, Jean Raymond

Abstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Article
  8. Article
  9. Article
  10. Stent-assisted coiling using the pEGASUS-HPC stent for acutely ruptured wide-necked intracranial aneurysms: A multicenter retrospective study.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2025
    Article
  11. Article
  12. Article
  13. ClippingInterventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2024
    Review
  14. Review
  15. Article
  16. Article
  17. Aneurysmal Subarachnoid Hemorrhage: the Last Decade.Translational stroke research · 2021
    Review
  18. Article
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Tim E DarsautUniversity of Alberta, Department of Surgery, Division of Neurosurgery, 2D,1 Mackenzie Health Sciences Center, 8440 - 112 St, Edmonton, AB T6G 2B7, Canada. tdarsaut@ualberta.ca
Andrew S Jack
Richard S Kerr
Jean Raymond

Funding

Canadian Institutes of Health Research MOP-119554
6 · The paper itself

Abstract

backgroundThe International Subarachnoid Aneurysm Trial (ISAT) demonstrated improved one-year clinical outcomes for patients with ruptured intracranial aneurysms treated with endovascular coiling compared to surgical clipping. Patients included in ISAT were mostly good grade subarachnoid hemorrhage (SAH) patients with small anterior circulation aneurysms. The purported superiority of coiling is commonly extrapolated to patients not studied in the original trial or to those treated using new devices not available at the time. Conversely, many patients are treated by clipping despite ISAT, because they are thought either to be better candidates for surgery, or to offer more durable protection from aneurysm recurrences. These practices have never been formally validated. Thus, for many ruptured aneurysm patients the question of which treatment modality leads to a superior clinical outcome remains unclear. METHODS/TRIAL

designISAT II is a pragmatic, multicenter, randomized trial comparing clinical outcomes for non-ISAT patients with subarachnoid hemorrhage allocated to coiling or clipping. Inclusion criteria are broad. The primary end-point is the incidence of poor clinical outcome (defined as mRS >2) at one year, just as in ISAT. Secondary end-points include measures of treatment safety for a number of pre-specified subgroups, with efficacy end-points including the presence of a major recurrence at one year; 1,896 patients (862 each arm plus 10% losses) are required to demonstrate a significant difference between coiling and clipping, hypothesizing 23% and 30% poor clinical outcome rates, for coiling and clipping, respectively. The trial should involve at least 50 international centers, and will take approximately 12 years to complete. Analysis will be by intention-to-treat.

Indexed as

Embolization, TherapeuticNeurosurgical ProceduresResearch DesignAneurysm, RupturedClinical ProtocolsHumansIntention to Treat AnalysisIntracranial AneurysmRecurrenceSubarachnoid HemorrhageTime FactorsTreatment Outcome

Identifiers

PMID23714335
PMCPMC3680206

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.