Recruiting

Aneurysm Management

Sponsor:

University of Alberta

Code:

NCT05161377

Conditions

Middle Cerebral Artery Aneurysm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Surgical management

Endovascular management

Study Details

Brief 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.

Conditions

Middle Cerebral Artery Aneurysm

Study ID

NCT05161377

Start date

May 15, 2022

Status verified date

Mar, 2026

Completion date

Jan 1, 2038

Anticipated

Primary completion date

Jan 1, 2036

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Surgical management

active comparator: Endovascular management

Interventions

Surgical 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.

Endovascular 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.

Primary outcome measure

  • Treatment Success [ Time Frame: up to 5 Years or until death, whichever came first ]

Central Contacts and Locations

Central contacts

Sudeshna Bhattacharyna

7804990974sbhattac@ualberta.ca

Locations

University of Alberta

Recruiting

Edmonton, Canada

Contacts

tim.darsaut@ualberta.ca

More Information

Sponsor

University of Alberta

Last update posted

Mar 13, 2026

Last verified

Mar, 2026

Keywords

  • Intracranial aneurysms

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-03-13.