The Canadian UnRuptured Endovascular Versus Surgery Trial,(CURES)
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.
To compare the results of surgical and endovascular management strategies, in terms of:
- Overall mortality and morbidity at 1 and 5 years.
- The clinical efficacy and safety of a surgical or endovascular management strategy at 1 and 5 years
Hypotheses: Phase 1 Hypotheses:
- Surgical clipping of intradural, saccular, unruptured intracranial aneurysms is superior to endovascular management in terms of a lesser number of patients experiencing treatment failure.
- 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:
- Overall morbidity and mortality at one year.
- Occurrence of morbidity (mRS >2) or mortality following treatment.
- Occurrence of failure of aneurysm occlusion using the initial intended treatment modality.
- Occurrence of a "major" (saccular) angiographic aneurysm recurrence.
- Occurrence of an intracranial hemorrhage following treatment.
- Peri-treatment hospitalization lasting more than 5 days
- Discharge following treatment to a location other than home
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:
- One management strategy is superior to the other in terms of clinical outcome at five years.
- One management strategy is superior to the other in terms of clinical efficacy at five years.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Title of Study: The Canadian UnRuptured Endovascular Versus Surgery Trial, a Randomized Comparison of Angiographic and Clinical Outcomes Following Treatment for Unruptured Intracranial Aneurysms.|
- 1. Intended initial modality fails to occlude the aneurysm: physician reporting. 2. A "major" (saccular) angiographic aneurysm recurrence: CTA or MRA. 3. Intracranial hemorrhagic event. [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
- 1. Morbidity and Mortality: Morbidity = modified Rankin scale score >2. 2. Hospitalization >5 days : physician reporting. 3. Discharge other than to home: physician reporting. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2010|
|Estimated Primary Completion Date:||June 2020 (Final data collection date for primary outcome measure)|
Procedure/surgery Endovascular, Surgery
All patients will be either having Endovascular Treatment or Surgery. All will have treatment.
Procedure: Endovascular, Surgery
If either Endovascular Treatment or Surgery have not completely occluded the aneurysm, in the opinion of the Physician, then cross over may occur.
|Contact: J M Findlay, PhDfirstname.lastname@example.org|
|Contact: Brenda D Poworoznikemail@example.com|
|University of Alberta Hospital||Recruiting|
|Edmonton, Alberta, Canada, T6G 2B7|
|Principal Investigator: J M Findlay, PHD|
|Principal Investigator:||Tim Darsaut, MD||Université de Montréal|
|Principal Investigator:||Jean Raymond, MD||Université de Montréal|