Clinical trial NCT01139892: The Canadian UnRuptured Endovascular Versus Surgery Trial (CURES)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Aneurysms
Keywords: Unruptured aneurysm
endovascular treatment
surgical treatment
randomized
intracranial aneurysm
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Centre de Recherche du Centre Hospitalier de l'Université de Montréal
name: University of Alberta
First posted: 2010-06-09
Enrollment: 291
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primary care clinic

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.


Eligibility criteria: Inclusion Criteria:

* Patients at least 18 years of age with at least 10 years of remaining life expectancy
* At least one documented, intradural, saccular intracranial aneurysm
* The patient and aneurysm are considered appropriate for either surgical or endovascular treatment by the treating team
* Aneurysm size 3-25 mm

Exclusion Criteria:

* Patients with any intracranial hemorrhage, including SAH, within the previous 30 days
* Lesion characteristics not readily suitable for either endovascular or surgical treatment, in the opinion of the physician(s) intending to treat the aneurysm
* Multiple aneurysms, where the treatment plan includes both surgical clipping as well as endovascular coiling
* Aneurysm anticipated (pre-operatively) to require proximal vessel occlusion, a bypass, or other flow-redirecting therapy (such as flow-diverting stents) as part of treatment plan
* Patients with baseline mRS \>2
* Patients with a single cavernous aneurysm
* Patients with dissecting, fusiform, or mycotic aneurysms
* Patients with AVM-associated aneurysms
* Pregnant patients (randomization (and treatment) may be delayed until after delivery)
* Patients with absolute contraindications to anaesthesia, endovascular treatment or administration of contrast material, including low-osmolarity agents or gadolinium
* Patients unable to give informed consent

Primary outcomes:
measure: Treatment failure
timeFrame: One Year
Secondary outcomes:
measure: Morbidity and mortality: 2. Hospitalization >5 days : physician reporting. 3. Discharge other than to home: physician reporting.
timeFrame: one year
measure: Occurrence of morbidity (mRS >2) or mortality following treatment.
timeFrame: 6 weeks post-treatment
measure: Failure of aneurysm occlusion
timeFrame: 1 year
measure: Occurrence of a "major" (saccular) angiographic aneurysm recurrence.
timeFrame: 1 year
measure: Occurrence of an intracranial hemorrhage
timeFrame: 1 year
measure: Hospitalization lasting more than 5 days
timeFrame: 6-weeks post-treatment
measure: Discharge following treatment to a location other than home
timeFrame: 6-weeks post-treatment
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: Centre hospitalier universitaire de Liège
city: Calgary
country: Canada
facility: Foothills Medical Center
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Ottawa
country: Canada
facility: Ottawa Hospital
state: Ontario
city: Montreal
country: Canada
facility: Centre hospitalier de l'Université de Montréal - CHUM
state: Quebec
city: Lille
country: France
facility: CHRU de Lille
Study officials:
affiliation: University of Alberta
name: Tim Darsaut, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Montréal
name: Jean Raymond, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Naggara O, Darsaut T, Trystram D, Tselikas L, Raymond J. Unruptured intracranial aneurysms: why we must not perpetuate the impasse for another 25 years. Lancet Neurol. 2014 Jun;13(6):537-8. doi: 10.1016/S1474-4422(14)70091-2. No abstract available.