Middle Cerebral Artery Aneurysm Trial

NCT05161377 | Recruiting DMC

• 1 other identifier: PRO-00116285
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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

Keywords

Intracranial aneurysms

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 5 Years or until death, whichever came first

Secondary Outcomes (2)

• The occurrence of an intracranial hemorrhage following treatment

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

• Failure of aneurysm occlusion using the intended treatment modality

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

Other Outcomes (3)

• Overall mortality

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

• Overall morbidity

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

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

  at one year (12 ± 2 months)

Study Arms (2)

Surgical management

ACTIVE COMPARATOR

Procedure: Surgical management

Endovascular management

ACTIVE COMPARATOR

Procedure: Endovascular management

Interventions

Surgical management PROCEDURE

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.

Surgical management

Endovascular management PROCEDURE

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.

Endovascular management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients at least 18 years of age
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Canada

RECRUITING

Related Publications (1)

• Darsaut TE, Keough MB, Boisseau W, Findlay JM, Bojanowski MW, Chaalala C, Iancu D, Weill A, Roy D, Estrade L, Lejeune JP, Januel AC, Carlson AP, Sauvageau E, Al-Jehani H, Orlov K, Aldea S, Piotin M, Gaberel T, Gevry G, Raymond J. Middle Cerebral Artery Aneurysm Trial (MCAAT): A Randomized Care Trial Comparing Surgical and Endovascular Management of MCA Aneurysm Patients. World Neurosurg. 2022 Apr;160:e49-e54. doi: 10.1016/j.wneu.2021.12.083. Epub 2021 Dec 28.

  PMID: 34971833 DERIVED

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Tim Darsaut

  University of Alberta Faculty of Medicine and Dentistry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sudeshna Bhattacharyna

CONTACT

7804990974; sbhattac@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: December 17, 2021
• Study Start: May 15, 2022
• Primary Completion (Estimated): January 1, 2036
• Study Completion (Estimated): January 1, 2038
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Indefinitely

Locations

CA (1)