The Canadian UnRuptured Endovascular Versus Surgery Trial,(CURES)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2011 by University of Alberta
Sponsor:
Information provided by:
University of Alberta
ClinicalTrials.gov Identifier:
NCT01139892
First received: June 2, 2010
Last updated: April 28, 2011
Last verified: April 2011
  Purpose

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.

Condition Intervention Phase
Aneurysms
Procedure: Endovascular, Surgery
Phase 1
Phase 2

Study Type: Observational
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.

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 250
Study Start Date: June 2010
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Other Names:
  • Arm 1: Endovascular
  • Arm 2: Surgery

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

primary care clinic

Criteria

Inclusion Criteria:

  • Patients at least 18 years of age with at least 10 years of remaining life expectancy
  • At least one documented, never ruptured, 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 12 months
  • Patients with previously incompletely treated intracranial aneurysm
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01139892

Contacts
Contact: J M Findlay, PhD 780-407-3548 max.findlay@albertahealthservices.ca
Contact: Brenda D Poworoznik 780-863-5354 brenda.poworoznik@albertahealthservices.ca

Locations
Canada, Alberta
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Principal Investigator: J M Findlay, PHD         
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Tim Darsaut, MD Université de Montréal
Principal Investigator: Jean Raymond, MD Université de Montréal
  More Information

No publications provided by University of Alberta

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr J Max Findlay, University of Alberta
ClinicalTrials.gov Identifier: NCT01139892     History of Changes
Other Study ID Numbers: CURES
Study First Received: June 2, 2010
Last Updated: April 28, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Alberta:
Unruptured aneurysm, endovascular treatment, surgical treatment, randomized

Additional relevant MeSH terms:
Aneurysm
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014