Middle Cerebral Artery Aneurysm Trial

ConditionMiddle Cerebral Artery Aneurysm

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Alberta

About this trial

Intracranial aneurysms located on the middle cerebral artery (MCA) are considered by many surgeons to represent a distinct subgroup of aneurysms for which clipping may still be the best management option. Most MCA aneurysms are accessible, proximal control can readily be secured in case of rupture, and clip application can typically proceed without requiring the dissection of perforating arteries. In comparison, certain anatomic features of MCA aneurysms such as a wide neck, often including a branch artery origin, frequently render endovascular management more difficult. New endovascular devices were and continue to be introduced to address these anatomic difficulties, including stents, flow diverters, and intra-saccular flow disruptors (ISFDs) such as the WEB. Thus, while most aneurysms are increasingly treated with endovascular methods, many MCA aneurysm patients are still managed surgically, but convincing evidence of which management paradigm is best is lacking.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients at least 18 years of age

At least one documented, intradural, intracranial aneurysm anywhere on the course of the MCA vessel, ruptured or unruptured. An untreated ruptured aneurysm (with delay in diagnosis) which is suspected to have occurred more than 30 days prior to study inclusion will be considered an unruptured aneurysm

In the case of SAH, WFNS grade 4 or less

The patient and aneurysm are considered appropriate for either surgical or endovascular treatment by the treating team

Disqualifiers

Patients with absolute contraindications administration of contrast material (any type)

Patients with AVM-associated aneurysms

Patients or caregivers unable to provide consent

Poor grade (WFNS 5) ruptured aneurysms

Trial design

Design model

Parallel

Treatments tested in this trial

Surgical management
Procedure/Surgery
Surgical clipping will be performed 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 aneurysms are expected to be more difficult lesions to manage surgically as well as endovascularly.
Endovascular management
Procedure/Surgery
Endovascular treatment will also be performed 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, flow-diverters, ISFD/WEBs or other innovative devices, as well as post- treatment medical management issues, will be left up to the physician performing the endovascular treatment and initial strategies determined prior to randomization.

Treatment groups

400 Participants

are divided into 2 treatment groups

Group A: Surgical managementActive comparator 1 intervention

Group B: Endovascular managementActive comparator 1 intervention

Trial outcomes

Primary outcomes

Treatment Success

The primary composite outcome measure is Treatment Success, a 5-part composite comprising: 1) occlusion or exclusion of the aneurysm using the allocated treatment modality; 2) no intracranial hemorrhage during follow-up; 3) no re-treatment of the target aneurysm during follow-up, 4) no residual aneurysm at 1 year; 5) independence (mRS \<3) at 1 year.

Time frame

up to 5 Years or until death, whichever came first

Secondary outcomes

The occurrence of an intracranial hemorrhage following treatment

An intracranial hemorrhage or re-bleed 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

Follow-up for 5 Years or until death, whichever came first

Failure of aneurysm occlusion using the intended treatment modality

This will be judged by the treating physician immediately following the attempted treatment.

Time frame

Follow-up for 5 Years or until death, whichever came first

Other outcomes

Overall mortality

Mortality from all causes will be recorded, along with cause of death, at one and five years.

Time frame

Follow-up for 5 Years or until death, whichever came first

Overall morbidity

Morbidity from all causes will be recorded, at one and five years.

Time frame

Follow-up for 5 Years or until death, whichever came first

The presence of a residual aneurysm at one year (12 ± 2 months)

This end-point will be determined using non-invasive angiography (CTA or MRA) performed at 12 ± 2 months post-treatment, with all images sent to MCAAT headquarters for Core Lab confirmation.

Time frame

at one year (12 ± 2 months)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alberta

Lead sponsor

Source ClinicalTrials.gov

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