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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01139892
|Contact: J M Findlay, PhDemail@example.com|
|Contact: Brenda D Poworoznikfirstname.lastname@example.org|
|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|