An interventional study of surgical management and Endovascular management in Intracranial Hemorrhage Ruptured Aneurysm, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Active, not recruiting at 6 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-15.
Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Not applicable, Interventional, and Treatment
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Among 10 studies in Intracranial Aneurysm by Centre hospitalier de l'Université de Montréal (CHUM) — 2 open to participants now, 3 under way, none of them phase 3. Intracranial Aneurysm · Centre hospitalier de l'Université de Montréal (CHUM).
Among the 10 studies in Intracranial Aneurysm by Centre hospitalier de l'Université de Montréal (CHUM), this one is the only one that started in 2012, is one of 8 with no phase, and was the 6th registered.
418 studies on the registry are indexed under Intracranial Aneurysm; 119 are open to participants now.
Browse Intracranial Aneurysm studies →2 of the 10 studies in Intracranial Aneurysm by Centre hospitalier de l'Université de Montréal (CHUM) are open now, in 3 countries. Recruiting first, the newest first:
Centre hospitalier de l'Université de Montréal (CHUM) · Sites in Canada, France, Italy
Ages 18+
Centre hospitalier de l'Université de Montréal (CHUM) · Sites in Canada
Ages 18+
By country, each count listing its studies:
Of the 82 Intracranial Aneurysm studies recruiting now, 49 (60%) set no upper age limit and 14 (17%) stop at 75 or younger; 15 take children under 18; 6 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 1 started in 2012.
This study's planned enrollment of 1,724 is above the median of 100 across 207 interventional studies indexed under Intracranial Aneurysm.
Median enrollment 250 across the 9 interventional studies, 291 across the 1 observational. Of the 6 that completed or were terminated, 3 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 376 studies on the registry; 110 are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Intracranial Aneurysm by Centre hospitalier de l'Université de Montréal (CHUM), from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to compare the clinical outcome of surgical clipping and endovascular coiling for ruptured intracranial aneurysms not included in the original ISAT Study.
The International Subarachnoid Aneurysm Trial (ISAT) was a turning point in modern neurosurgical history (1). The trial showed that for 2143 subarachnoid hemorrhage (SAH)patients eligible for both surgery and endovascular coiling, randomized allocation to coiling was associated with better one year clinical outcomes, defined as survival without dependency (absolute risk reduction (ARR) of 7.4% (95%CI; 3.6 - 11.2, p=0.0001). Because ISAT was a positive pragmatic trial, the interpretation of the trial results was that coiling should be adopted as the first-line treatment for ruptured lesions, for patients with the types of aneurysms included in ISAT, of which the great majority were small (≥10 mm) anterior circulation aneurysms.
Although ISAT was well-designed, conducted, and reported, trial results were not always properly interpreted, and endovascular coiling was perhaps inappropriately extrapolated beyond what ISAT demonstrated. Endovascular treatment for ruptured aneurysms has now become first-line treatment in many centers (2), which may be appropriate for small, anterior circulation lesions, but there is no evidence to support this practice for the wide spectrum of non-ISAT patients and aneurysms. A recent pre-randomized study of coiling as first-intention (3)showed better results for those ruptured aneurysms felt to be readily coilable; however, the optimal management of more difficult-to-coil ruptured aneurysms remains unclear.
Further compounding the problem are the concerns that aneurysm coiling may not be as durable in the long-term as surgical clipping, leading many neurosurgeons to continue to clip most ruptured aneurysms in spite of ISAT results.
Proponents of endovascular treatment sometimes justify this extrapolation of ISAT results on the basis of improved catheter and coil technology, although this has never been demonstrated. However, the addition of stents and flow-diverters, which were not tested in ISAT, may increase endovascular treatment risks, especially when combined with dual anti-platelet agents. The introduction of these devices allowed for the expansion of indications of EVT to include wide-necked aneurysms, lesions which would not have been included in ISAT. The wider spectrum of patients and aneurysms now considered for EVT may not all experience the same degree of benefit as seen in the original ISAT trial (4). Considering the relatively small ARR of 7.4% favouring coiling, when the additional risks due to stents are included, the balance may have tipped to favour surgical clipping.
These new questions deserve formal study in the context of a randomized clinical trial.
418 studies on the registry are indexed under Intracranial Aneurysm; 119 are open to participants now.
This study's planned enrollment of 1,724 is above the median of 100 across 207 interventional studies indexed under Intracranial Aneurysm.
Browse Intracranial Aneurysm studies →Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 376 studies on the registry; 110 are open to participants now.
Compared within Intracranial Aneurysm, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Aneurysm. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Endovascular treatment will be performed as soon as possible following randomization, according to standards of practice, and under general anesthesia. Details regarding type of coils, use of adjunctive techniques such as balloon-remodeling, stents or flow-diverters, as well as post-treatment medical management issues, will be left up to the physician performing the endovascular treatment.
Procedure: Endovascular management
Surgical clipping will be performed as soon as possible following randomization, according to standards of practice, and under general anesthesia. Aneurysms thought by the treating physicians to require deliberate permanent proximal vessel occlusion, construction of a surgical bypass, or other flow-redirecting treatments that do not directly clip the aneurysm will not be excluded; these non-ISAT aneurysms are expected to be more difficult lesions to manage surgically as well as endovascularly.
Procedure: surgical management
Surgical clipping will be performed as soon as possible following randomization, according to standards of practice, and under general anesthesia. Aneurysms thought by the treating physicians to require deliberate permanent proximal vessel occlusion, construction of a surgical bypass, or other flow-redirecting treatments that do not directly clip the aneurysm will not be excluded; these non-ISAT aneurysms are expected to be more difficult lesions to manage surgically as well as endovascularly.
Endovascular treatment will also be performed as soon as possible following randomization,according to standards of practice, and under general anesthesia. Details regarding type of coils, use of adjunctive techniques such as balloon-remodeling, stents or flow-diverters, as well as post-treatment medical management issues, will be left up to the physician performing the endovascular treatment.
poor clinical outcome(mRS>2)
Number of patients experiencing a poor clinical outcome at one year post-treatment, defined as a modified Rankin Scale (mRS) score of \>2.
Time frame: 12 months
Occurrence of an intracranial hemorrhage following treatment
An intracranial hemorrhage will be judged from cross-sectional imaging (CT or MRI), from a positive lumbar puncture in the setting of an acute headache, or following sudden death preceded by an acute headache.
Time frame: one year
Failure of aneurysm occlusion using the intended treatment modality
In situations where treatment is initiated but terminated without a proper test of that treatment modality, such as in the event of anaesthetic difficulty requiring the intended treatment to be delayed, will not count as a failure. However, 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.
Time frame: within 48 hours after attempted treatment
Overall mortality and morbidity
Mortality and morbidity from all causes will be recorded, along with cause of death, at one and five years.
Time frame: one year and five years
Occurence of a "major" (saccular) aneurysm recurrence
Determined using non-invasive angiography (CTA or MRA)as part of normal follow-up after aneurysm treatment. Although DSA, CTA and MRA are known to have different sensitivities in detecting aneurysm remnants,these modalities are equally well-suited to the discovery of a concerning, saccular aneurysm residual or remnant.
Time frame: 12 months (+/- 2 months)
Peri-treatment hospitalization lasting more than 20 days and/or discharge to a location other than home
Will be recorded by the local treating physician upon discharge.
Time frame: within a month or at discharge if earlier
Occurence of aneurysm re-rupture following randomization but before treatment initiation
Repeat intracranial hemorrhage will be judged from cross-sectional imaging (CT scan), after worsening of headache, or following a new-onset neurological deficit or sudden death while awaiting treatment.
Time frame: Within a few hours (while awaiting treatment)
Started Nov 2012 (actual). Primary completion is estimated for Dec 2024, 145 months after the start.
Of 56 non-industry interventional studies with no phase under Intracranial Aneurysm, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 134. This study's planned 145 months is above that.
Counting every sponsor, half of 104 studies reached it within 39 months; a quarter within 22 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Centre hospitalier de l'Université de Montréal (CHUM) →