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. 2018 Aug 15;2018(8):CD003085. doi: 10.1002/14651858.CD003085.pub3

ISAT‐2.

Trial name or title International Subarachnoid Aneurysm Trial 2
Methods Method of randomisation: centralised minimisation procedure via web platform
Minimisation criteria to be balanced between groups: age ≥ 70 years, WFNS grade > III, aneurysm size > 3 cm, posterior circulation location of aneurysm
Participants Target sample size: 1896 participants, expected loss to follow‐up < 10%
Listed location countries: Canada, Spain, US
Inclusion criteria
  • Aged ≥ 18 years

  • ≥ 1 documented, intradural, intracranial aneurysm, ruptured within last 30 days

  • SAH WFNS ≤ grade IV

  • Participant and aneurysm considered appropriate for either surgical or endovascular treatment by the treating team


Exclusion criteria
  • People with absolute contraindications administration of contrast material (any type)

  • People with AVM‐associated aneurysms

  • Aneurysm located at basilar apex

Interventions Surgical management of the ruptured aneurysm
Endovascular management (including use of adjunctive techniques such as flow‐diverting stents and WEB devices in addition to coiling)
Outcomes Primary outcome
  • Poor clinical outcome (mRS > 2) at 12 months


Secondary outcomes
  • Aneurysm haemorrhage following treatment within 12 months

  • Failure of aneurysm occlusion using the intended treatment modality within 48 hours of attempted treatments

  • Overall mortality and morbidity from all causes at 1 and 5 years

  • Occurrence of major aneurysm recurrence within 12 months (SD 2 months)

  • Peritreatment hospitalisation > 20 days or discharge to a location other than home, or both

  • Occurrence of aneurysm rerupture following randomisation but before treatment initiation

Starting date October 2012
Contact information clinicaltrials.gov/ct2/show/record/NCT01668563
Notes Estimated primary completion date: 2023

AVM: arteriovenous malformation; mRS: modified Rankin scale; SAH: subarachnoid haemorrhage; WEB: Wowen EndoBridge; WFNS: World Federation of Neurological Surgeons subarachnoid haemorrhage grading scale.