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

Inclusion Criteria4

  • 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

Exclusion Criteria4

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05161377