Ignite Creation Date:
2024-05-06 @ 12:50 AM
Last Modification Date:
2024-10-26 @ 10:55 AM
Study NCT ID:
NCT01668563
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-07-06
First Post:
2012-08-15
Brief Title:
International Subarachnoid Aneurysm Trial II
Sponsor:
Centre hospitalier de lUniversité de Montréal CHUM
Organization:
Centre hospitalier de lUniversité de Montréal CHUM
Study Overview
Official Title:
International Subarachnoid Aneurysm Trial II Comparing Clinical Outcomes of Surgical Clipping and Endovascular Coiling for Ruptured Intracranial Aneurysms Not Included in the Original ISAT Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ISATII
Brief Summary:
The purpose of this study is to compare the clinical outcome of surgical clipping and endovascular coiling for ruptured intracranial aneurysms not included in the original ISAT Study
Detailed Description:
The International Subarachnoid Aneurysm Trial ISAT was a turning point in modern neurosurgical history 1 The trial showed that for 2143 subarachnoid hemorrhage SAHpatients eligible for both surgery and endovascular coiling randomized allocation to coiling was associated with better one year clinical outcomes defined as survival without dependency absolute risk reduction ARR of 74 95CI 36 - 112 p00001 Because ISAT was a positive pragmatic trial the interpretation of the trial results was that coiling should be adopted as the first-line treatment for ruptured lesions for patients with the types of aneurysms included in ISAT of which the great majority were small 10 mm anterior circulation aneurysms
Although ISAT was well-designed conducted and reported trial results were not always properly interpreted and endovascular coiling was perhaps inappropriately extrapolated beyond what ISAT demonstrated Endovascular treatment for ruptured aneurysms has now become first-line treatment in many centers 2 which may be appropriate for small anterior circulation lesions but there is no evidence to support this practice for the wide spectrum of non-ISAT patients and aneurysms A recent pre-randomized study of coiling as first-intention 3showed better results for those ruptured aneurysms felt to be readily coilable however the optimal management of more difficult-to-coil ruptured aneurysms remains unclear
Further compounding the problem are the concerns that aneurysm coiling may not be as durable in the long-term as surgical clipping leading many neurosurgeons to continue to clip most ruptured aneurysms in spite of ISAT results
Proponents of endovascular treatment sometimes justify this extrapolation of ISAT results on the basis of improved catheter and coil technology although this has never been demonstrated However the addition of stents and flow-diverters which were not tested in ISAT may increase endovascular treatment risks especially when combined with dual anti-platelet agents The introduction of these devices allowed for the expansion of indications of EVT to include wide-necked aneurysms lesions which would not have been included in ISAT The wider spectrum of patients and aneurysms now considered for EVT may not all experience the same degree of benefit as seen in the original ISAT trial 4 Considering the relatively small ARR of 74 favouring coiling when the additional risks due to stents are included the balance may have tipped to favour surgical clipping
These new questions deserve formal study in the context of a randomized clinical trial
Although ISAT was well-designed conducted and reported trial results were not always properly interpreted and endovascular coiling was perhaps inappropriately extrapolated beyond what ISAT demonstrated Endovascular treatment for ruptured aneurysms has now become first-line treatment in many centers 2 which may be appropriate for small anterior circulation lesions but there is no evidence to support this practice for the wide spectrum of non-ISAT patients and aneurysms A recent pre-randomized study of coiling as first-intention 3showed better results for those ruptured aneurysms felt to be readily coilable however the optimal management of more difficult-to-coil ruptured aneurysms remains unclear
Further compounding the problem are the concerns that aneurysm coiling may not be as durable in the long-term as surgical clipping leading many neurosurgeons to continue to clip most ruptured aneurysms in spite of ISAT results
Proponents of endovascular treatment sometimes justify this extrapolation of ISAT results on the basis of improved catheter and coil technology although this has never been demonstrated However the addition of stents and flow-diverters which were not tested in ISAT may increase endovascular treatment risks especially when combined with dual anti-platelet agents The introduction of these devices allowed for the expansion of indications of EVT to include wide-necked aneurysms lesions which would not have been included in ISAT The wider spectrum of patients and aneurysms now considered for EVT may not all experience the same degree of benefit as seen in the original ISAT trial 4 Considering the relatively small ARR of 74 favouring coiling when the additional risks due to stents are included the balance may have tipped to favour surgical clipping
These new questions deserve formal study in the context of a randomized clinical trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None