Ignite Creation Date:
2025-12-24 @ 3:26 PM
Ignite Modification Date:
2025-12-29 @ 5:48 PM
Study NCT ID:
NCT01139892
Status:
COMPLETED
Last Update Posted:
2023-07-06
First Post:
2010-06-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Canadian UnRuptured Endovascular Versus Surgery Trial (CURES)
Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Organization:
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:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CIHR; MOP119554 | OTHER_GRANT | Grant to CHUM Research Centre to Dr. Jean Raymond. | View |