Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04155606

The Comprehensive Aneurysm Management Trial

Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2025-07-28

2000

Participants Needed

6

Research Sites

52 weeks

Total Duration

On this page

Sponsors

C

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

U

University of Alberta

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the best management of patients with unruptured intracranial aneurysms (UIAs), a condition where the optimal treatment approach remains uncertain after 30 years of study. This trial aims to compare active treatments like microsurgical clipping and endovascular interventions with conservative management to determine which provides better long-term outcomes. The study also addresses ethical concerns surrounding offering risky preventive treatments without proven benefits and strives to include all patients facing this clinical dilemma. The trial includes multiple groups where patients may receive either neurosurgery or endovascular procedures, such as coiling or stenting, or be monitored with pharmacological therapy if needed. Treatment decisions involve clinical judgment combined with randomized allocation to either active treatment or conservative management. Patients who undergo treatment will have follow-up visits approximately 6 to 12 weeks after treatment, then at 1, 5, and 10 years with imaging studies to monitor aneurysm status. Participants will be involved in long-term follow-up for 10 years, including clinical visits and imaging tests like CTA or MRA to assess aneurysm recurrence and overall health. Researchers will measure survival without neurological dependency as the primary outcome and secondary outcomes such as incidence of subarachnoid hemorrhage, treatment-related morbidity and mortality, overall mortality and morbidity at specific time points, length of hospitalization, and discharge location. The study is designed to gather comprehensive data on UIA management with minimal exclusions and broad inclusion criteria.

CONDITIONS

Brief Title

Comprehensive Aneurysm Management Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with at least one documented intracranial subarachnoid aneurysm (cavernous aneurysms are excluded)
Not Eligible

You will not qualify if you...

  • Patients with any intracranial hemorrhage, including subarachnoid hemorrhage, within the previous 30 days
  • Patients with AVM-associated aneurysms
  • Patients unable to give informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 10 years of follow-up after treatment

Participants receive either neurosurgery or endovascular procedure as an active treatment for their unruptured intracranial aneurysms.

Clinic visits at approximately 6-12 weeks, 1 year, 5 years, and 10 years post-treatment; imaging at 12 ± 2 months post-treatment

Long-term Monitoring

Duration - Up to 10 years

Participants who undergo conservative management are monitored for aneurysm status and neurological outcomes over time.

Regular monitoring visits aligned with routine care; clinic visits at 1, 5, and 10 years

Trial Site Locations

Total: 6 locations

1

University of Alberta Hospital

Edmonton, Alberta, Canada, T6G 2R3

Actively Recruiting

2

Daniel Roy

Montreal, Quebec, Canada, H2X 3E4

Actively Recruiting

3

Centre Hospitalier Régional Universitaire de Tours

Tours, France

Actively Recruiting

4

ASST Ospedale Papa Giovanni XXIII

Bergamo, Italy

Actively Recruiting

5

Ospedale Vito Frazzi

Lecce, Italy, 73100

Actively Recruiting

6

Ospedale San Carlo Borromeo di Milano

Milan, Italy

Actively Recruiting

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Research Team

T

Tim Darsaut, MD, MSc

J

Jean Raymond, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Frequently Asked Questions

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