The Canadian UnRuptured Endovascular Versus Surgery Trial (CURES)

NCT01139892 | Completed DMC

• 2 other identifiers: ND09.282CIHR; MOP119554
• Study Type: observational
• Target: 291
• Locations: 3 countries
• Sites: 6

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. 1.Overall mortality and morbidity at 1 and 5 years.
2. 2.The clinical efficacy and safety of a surgical or endovascular management strategy at 1 and 5 years
3. 3.Surgical clipping of intradural, saccular, unruptured intracranial aneurysms is superior to endovascular management in terms of a lesser number of patients experiencing treatment failure.
4. 4.An RCT comparing the clinical outcomes of a surgical versus endovascular management strategy is feasible.
5. 5.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:
6. 6.Overall morbidity and mortality at one year.
7. 7.Occurrence of morbidity (mRS \>2) or mortality following treatment.
8. 8.Occurrence of failure of aneurysm occlusion using the initial intended treatment modality.
9. 9.Occurrence of a "major" (saccular) angiographic aneurysm recurrence.
10. 10.Occurrence of an intracranial hemorrhage following treatment.
11. 11.Peri-treatment hospitalization lasting more than 5 days
12. 12.Discharge following treatment to a location other than home
13. 13.One management strategy is superior to the other in terms of clinical outcome at five years.
14. 14.One management strategy is superior to the other in terms of clinical efficacy at five years.

Conditions

Intracranial Aneurysms

Keywords

Unruptured aneurysm; endovascular treatment; surgical treatment; randomized; intracranial aneurysm

Outcome Measures

Primary Outcomes (1)

• 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.

  One Year

Secondary Outcomes (7)

• Morbidity and mortality: 2. Hospitalization >5 days : physician reporting. 3. Discharge other than to home: physician reporting.

  one year

• Occurrence of morbidity (mRS >2) or mortality following treatment.

  6 weeks post-treatment

• Failure of aneurysm occlusion

  1 year

• Occurrence of a "major" (saccular) angiographic aneurysm recurrence.

  1 year

• Occurrence of an intracranial hemorrhage

  1 year

Study Arms (2)

Surgical management

Surgical clipping will be performed within 6 weeks of randomization, according to standards of practice, and under general anaesthesia. Aneurysms thought by the treating physicians to require deliberate permanent proximal vessel occlusion, bypasses, and other flow-redirecting treatments that do not directly clip the aneurysm will not be included.

Procedure: Surgical management

Endovascular management

Endovascular treatment will be performed within 6 weeks of randomization, according to standards of practice, and under general anaesthesia. Details regarding type of coils, use of adjunctive techniques such as balloon-remodeling or stents, as well as post-treatment medical management issues, will be left up to the physician performing the endovascular treatment.

Procedure: Endovascular management

Interventions

Surgical management PROCEDURE

Also known as: Arm 1: clipping

Surgical management

Endovascular management PROCEDURE

Also known as: Arm 2: coiling

Endovascular management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

primary care clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Centre de Recherche du Centre Hospitalier de l'Université de Montréal: collaborator
• University of Alberta: collaborator

Study Sites (6)

Centre hospitalier universitaire de Liège

Liège, Belgium

Location

Foothills Medical Center

Calgary, Alberta, T2N 2T9, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Centre hospitalier de l'Université de Montréal - CHUM

Montreal, Quebec, H2X 0C1, Canada

Location

CHRU de Lille

Lille, France

Location

Related Publications (1)

• 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.

  PMID: 24849854 DERIVED

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Tim Darsaut, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Jean Raymond, MD

  Université de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2010
• First Posted: June 9, 2010
• Study Start: September 26, 2010
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: July 6, 2023

Record last verified: 2023-07

Locations

CA (4); BE (1); FR (1)