Intracranial AneurysmsCURESNCT01139892
The Canadian UnRuptured Endovascular Versus Surgery Trial (CURES)
An observational study of Intracranial Aneurysms, run by Centre hospitalier de l'Université de Montréal (CHUM) at 6 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Aneurysms
- What is being tested?
- Surgical management and Endovascular management
- Type of treatment
- Surgery or procedure
- How many people
- 291 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 26 Sep 2010to Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: primary care clinic
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Canada4 sites
Foothills Medical Center
Calgary, Alberta, T2N 2T9
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Centre hospitalier de l'Université de Montréal - CHUM
Montreal, Quebec, H2X 0C1
Ottawa Hospital
Ottawa, Ontario, K1H 8L6
About this study
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
Purpose:
Phase 1: (Pilot Phase)
Read more
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:
- 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
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:
- 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.
- Conditions
- Intracranial Aneurysms
- Being tested
- Surgical management, Endovascular management
- Keywords
- Unruptured aneurysm, endovascular treatment, surgical treatment, randomized, intracranial aneurysm
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical managementProcedure or surgery
Also called Arm 1: clipping
Endovascular managementProcedure or surgery
Also called Arm 2: coiling
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Endovascular management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One Year
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 1 year
Occurrence of a "major" (saccular) angiographic aneurysm recurrence.
Occurrence of a "major" (saccular) angiographic aneurysm recurrence.
Measured: 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.
Measured: 1 year
Hospitalization lasting more than 5 days
This end-point will be recorded by the local treating physician on discharge.
Measured: 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.
Measured: 6-weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2010 (estimated)
- Study start26 Sep 2010
- Primary completionOct 2022
- Study completionOct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracranial AneurysmsStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 291 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche du Centre Hospitalier de l'Université de Montréal, University of Alberta
- Responsible party
- Sponsor
- Investigators
- Tim Darsaut, MD, Principal investigator, University of AlbertaJean Raymond, MD, Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01139892
- Sponsor's protocol ID
- ND09.282
- Other IDs
- CIHR; MOP119554
- Acronym
- CURES
- Status last verified
- Jul 2023
- First submitted
- 2 Jun 2010
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24849854
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01139892
- Acronym / sponsor ID
- CURES / ND09.282
- Conditions
- Intracranial Aneurysms
- Keywords
- Unruptured aneurysm, endovascular treatment, surgical treatment, randomized, intracranial aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 291 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Centre de Recherche du Centre Hospitalier de l'Université de Montréal, University of Alberta
- Study start
- 26 Sep 2010 (actual)
- Primary completion
- Oct 2022 (actual)
- Study completion
- Oct 2022 (actual)
- First posted
- 9 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
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:
- 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
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical management | – | Procedure: Surgical managementSurgical 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. |
| Endovascular management | – | Procedure: Endovascular managementEndovascular 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical managementAlso: Arm 1: clipping | Procedure or surgery | Surgical management |
| Endovascular managementAlso: Arm 2: coiling | Procedure or surgery | Endovascular management |
Primary outcome
Treatment failure
Time frame: One Year
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.
7 secondary outcomes
Morbidity and mortality: 2. Hospitalization >5 days : physician reporting. 3. Discharge other than to home: physician reporting.
Time frame: one year
Occurrence of morbidity (mRS >2) or mortality following treatment.
Time frame: 6 weeks post-treatment
Failure of aneurysm occlusion
Time frame: 1 year
Occurrence of a "major" (saccular) angiographic aneurysm recurrence.
Time frame: 1 year
Occurrence of an intracranial hemorrhage
Time frame: 1 year
Hospitalization lasting more than 5 days
Time frame: 6-weeks post-treatment
Discharge following treatment to a location other than home
Time frame: 6-weeks post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Derived from this study: PubMed 24849854Naggara 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Darsaut, MD principal investigator
University of Alberta
Jean Raymond, MD principal investigator
Université de Montréal
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysms, run by Centre hospitalier de l'Université de Montréal (CHUM) at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada, Belgium, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure (time frame: One Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01139892, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.