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.
Study Type
OBSERVATIONAL
Enrollment
291
Centre hospitalier universitaire de Liège
Liège, Belgium
Foothills Medical Center
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Ottawa Hospital
Ottawa, Ontario, Canada
Centre hospitalier de l'Université de Montréal - CHUM
Montreal, Quebec, Canada
CHRU de Lille
Lille, France
Treatment failure
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.
Time frame: One Year
Morbidity and mortality: 2. Hospitalization >5 days : physician reporting. 3. Discharge other than to home: physician reporting.
Overall morbidity and mortality at one year. Morbidity = modified Rankin scale score \>2. The Modified Rankin Scale score will be determined by an independent health-care professional, not directly involved in the CURES study, and blinded to treatment allocation.
Time frame: one year
Occurrence of morbidity (mRS >2) or mortality following treatment.
Occurrence of morbidity (mRS \>2) or mortality following treatment. The Modified Rankin Scale score will be determined by an independent health-care professional, not directly involved in the CURES study, and blinded to treatment allocation.
Time frame: 6 weeks post-treatment
Failure of aneurysm occlusion
Occurrence of failure of aneurysm occlusion using the initial intended treatment modality as determined by the local treating physician. Patients left with clinically concerning aneurysm residuals (in the opinion of the treating physician) after the treatment attempt will count as a failure of the initial treatment. In the surgically-treated patients, the surgeon's judgment of whether or not the aneurysm is fully occluded with the clip will be used to determine failure of aneurysm occlusion. Because the primary end-points in Phase 1 is a composite end-point, it does not distinguish between aneurysm remnants found immediately post-treatment (failure to completely occlude the aneurysm) and recurrences (or residuals) found at one-year post-treatment. Even if a surgically-treated aneurysm felt to be completely occluded by the surgeon is in fact inadequately treated, this will be found at the one year follow-up imaging mark, and thus does not constitute a source of bias.
Time frame: 1 year
Occurrence of a "major" (saccular) angiographic aneurysm recurrence.
Occurrence of a "major" (saccular) angiographic aneurysm recurrence.
Time frame: 1 year
Occurrence of an intracranial hemorrhage
Determined using non-invasive angiography (CTA or MRA) performed at 12 +/- 2 months post-treatment, with all images sent to CURES headquarters for Core Lab confirmation. This follow-up imaging is considered to be part of normal follow-up after aneurysm treatment. Although CTA and MRA are known to have different sensitivities in detecting aneurysm remnants, both modalities are equally well-suited to the discovery of what we are looking for: a concerning, saccular aneurysm residual or remnant. Because the definition of "major", "concerning", or "saccular" aneurysm residual or remnant remains subjective, (as does the threshold for re-treatment) local investigators will be requested to record the occurrence of what they consider to be a "major" saccular recurrence, but the final determination of this end-point will be determined by an independent Core Lab.
Time frame: 1 year
Hospitalization lasting more than 5 days
This end-point will be recorded by the local treating physician on discharge.
Time frame: 6-weeks post-treatment
Discharge following treatment to a location other than home
This end-point will be recorded by the local treating physician on discharge.
Time frame: 6-weeks post-treatment
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