RecruitingNot ApplicableNCT05161377

Middle Cerebral Artery Aneurysm Trial

Middle Cerebral Artery Aneurysm Trial: A Randomized Care Trial Comparing Surgical and Endovascular Management of MCA Aneurysm Patients


Sponsor

University of Alberta

Enrollment

400 participants

Start Date

May 15, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (MCAT Trial) is comparing two treatment methods — surgical clipping versus minimally invasive endovascular coiling — for brain aneurysms located on the middle cerebral artery (MCA). Both approaches are already used in standard care; this trial aims to find out which is better. You may be eligible if: - You are 18 or older - You have at least one confirmed aneurysm on your middle cerebral artery (ruptured or unruptured) - If you had a brain bleed (SAH), your severity grade is 4 or less on the WFNS scale - Your medical team believes you are a candidate for either surgical or endovascular treatment You may NOT be eligible if: - You have a known allergy to contrast dye used in imaging - Your aneurysm is connected to a brain arteriovenous malformation (AVM) - You or your caregivers are unable to provide consent - You have a very severe brain bleed (WFNS grade 5) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESurgical management

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.

PROCEDUREEndovascular management

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.


Locations(1)

University of Alberta

Edmonton, Canada

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NCT05161377