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
Exclusion criteria
|
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
Secondary outcomes
|
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.