Ignite Creation Date:
2024-05-05 @ 10:33 PM
Last Modification Date:
2024-10-26 @ 10:21 AM
Study NCT ID:
NCT01139892
Status:
COMPLETED
Last Update Posted:
2023-07-06
First Post:
2010-06-02
Brief Title:
The Canadian UnRuptured Endovascular Versus Surgery Trial CURES
Sponsor:
Centre hospitalier de lUniversité de Montréal CHUM
Organization:
Centre hospitalier de lUniversité de Montréal CHUM
Study Overview
Official Title:
Canadian Study on the Endovascular Treatment of Unruptured Intracranial Aneurysms Versus Surgical Treatment A Randomized Comparison of Clinical and Angiographic Results of Intracranial Aneurysms
Status:
COMPLETED
Status Verified Date:
2023-07
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:
CURES
Brief Summary:
Purpose
Phase 1 Pilot Phase
To compare the treatment efficacy of surgical clipping and endovascular coiling for unruptured intracranial aneurysms
To obtain better estimates of morbidity and mortality related to a surgical or endovascular treatment strategy at one year within the context of an RCT
To show that an RCT comparing the morbidity and mortality of a surgical management strategy to an endovascular management strategy is feasible
Phase 2
To compare the results of surgical and endovascular management strategies in terms of
1 Overall mortality and morbidity at 1 and 5 years
2 The clinical efficacy and safety of a surgical or endovascular management strategy at 1 and 5 years
Hypotheses Phase 1 Hypotheses
1 Surgical clipping of intradural saccular unruptured intracranial aneurysms is superior to endovascular management in terms of a lesser number of patients experiencing treatment failure
2 An RCT comparing the clinical outcomes of a surgical versus endovascular management strategy is feasible
Phase 1 Primary End-points
Treatment failure hereby defined as having occurred when either the intended initial modality surgical or endovascular fails to occlude the aneurysm a major saccular angiographic aneurysm recurrence is found or an intracranial hemorrhagic event occurs during the 1-year follow-up period
Phase 1 Secondary End-points
1 Overall morbidity and mortality at one year
2 Occurrence of morbidity mRS 2 or mortality following treatment
3 Occurrence of failure of aneurysm occlusion using the initial intended treatment modality
4 Occurrence of a major saccular angiographic aneurysm recurrence
5 Occurrence of an intracranial hemorrhage following treatment
6 Peri-treatment hospitalization lasting more than 5 days
7 Discharge following treatment to a location other than home
Treatment
Trial feasibility or the capacity for patient recruitment would require enrollment of at least 8 patients per actively recruiting center per year
Phase 2 Hypotheses
It may be too early to explicitly define the primary hypothesis of Phase 2 however the intent of Phase 2 can be expressed as
1 One management strategy is superior to the other in terms of clinical outcome at five years
2 One management strategy is superior to the other in terms of clinical efficacy at five years
Phase 1 Pilot Phase
To compare the treatment efficacy of surgical clipping and endovascular coiling for unruptured intracranial aneurysms
To obtain better estimates of morbidity and mortality related to a surgical or endovascular treatment strategy at one year within the context of an RCT
To show that an RCT comparing the morbidity and mortality of a surgical management strategy to an endovascular management strategy is feasible
Phase 2
To compare the results of surgical and endovascular management strategies in terms of
1 Overall mortality and morbidity at 1 and 5 years
2 The clinical efficacy and safety of a surgical or endovascular management strategy at 1 and 5 years
Hypotheses Phase 1 Hypotheses
1 Surgical clipping of intradural saccular unruptured intracranial aneurysms is superior to endovascular management in terms of a lesser number of patients experiencing treatment failure
2 An RCT comparing the clinical outcomes of a surgical versus endovascular management strategy is feasible
Phase 1 Primary End-points
Treatment failure hereby defined as having occurred when either the intended initial modality surgical or endovascular fails to occlude the aneurysm a major saccular angiographic aneurysm recurrence is found or an intracranial hemorrhagic event occurs during the 1-year follow-up period
Phase 1 Secondary End-points
1 Overall morbidity and mortality at one year
2 Occurrence of morbidity mRS 2 or mortality following treatment
3 Occurrence of failure of aneurysm occlusion using the initial intended treatment modality
4 Occurrence of a major saccular angiographic aneurysm recurrence
5 Occurrence of an intracranial hemorrhage following treatment
6 Peri-treatment hospitalization lasting more than 5 days
7 Discharge following treatment to a location other than home
Treatment
Trial feasibility or the capacity for patient recruitment would require enrollment of at least 8 patients per actively recruiting center per year
Phase 2 Hypotheses
It may be too early to explicitly define the primary hypothesis of Phase 2 however the intent of Phase 2 can be expressed as
1 One management strategy is superior to the other in terms of clinical outcome at five years
2 One management strategy is superior to the other in terms of clinical efficacy at five years
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CIHR MOP119554 | OTHER_GRANT | Grant to CHUM Research Centre to Dr Jean Raymond | None |