Comprehensive Aneurysm Management Trial

NCT04155606 | Recruiting DMC

• 1 other identifier: 2020-9600
• Study Type: interventional
• Target: 2,000
• Locations: 3 countries
• Sites: 6

Brief Summary

The uncertainty regarding the management of Unruptured Intracranial Aneurysms (UIAs) has not progressed in the last 30 years. The fundamental ethical basis for this study is that physicians should only offer a risky preventive treatment when it has been shown to be beneficial. Before that, such treatment should be offered as an RCT. The CAM trial offers a comprehensive framework, so that all patients confronted with the clinical dilemma can be offered participation. The principal questions to be addressed are :

1. 1.do patients with UIAs, considered for curative treatments, have a better long-term clinical outcome with active treatment or conservative management?
2. 2.when patients are considered ineligible for conservative management, and surgical and endovascular management are both judged reasonable, do patients with UIAs have a better long-term clinical outcome with surgical or endovascular management? The primary hypothesis for patients allocated to at least 2 options, one of which is conservative management is: the 10 year combined neurological morbidity and mortality (mRS\>2) will be reduced from 24% to 16% (beta 80%; alpha 0.048; sample size 961 patients (836 plus 15% losses to FU and cross-overs) with active treatment.
3. 3.the incidence of SAH during follow-up and related morbidity and mortality;
4. 4.the morbidity and mortality related to endovascular or surgical treatment of the UIA at one year;
5. 5.overall mortality at 1, 5 and 10 years;
6. 6.overall morbidity (mRS\>2) at 1, 5 and 10 years;
7. 7.length of hospitalization;
8. 8.discharge to location other than home

Conditions

Saccular Aneurysm; Intracranial Aneurysm; Unruptured Cerebral Aneurysm

Keywords

Unruptured Intracranial Aneurysm; Endovascular treatment; Surgical treatment; Conservative management

Outcome Measures

Primary Outcomes (1)

• Survival without neurological dependency

  Number of patients without neurological dependency. Neurological dependency is defined as an outcome with a modified Rankin Score greater or equal to 3

  10 years

Secondary Outcomes (6)

• Sub-arachnoid hemorrhage (SAH)

  10 years

• morbi/mortality related to interventions

  1 year

• Overall mortality

  1, 5 and 10 years

• Overall morbidity

  1, 5 and 10 years

• Length of hospitalization

  10 years

Study Arms (2)

Interventional Therapy

ACTIVE COMPARATOR

Neurosurgery or Endovascular procedure

Device: microsurgery; endovascular interventions

Conservative Management

NO INTERVENTION

Monitoring with pharmacological therapy if need arises.

Interventions

microsurgery; endovascular interventions DEVICE

microsurgery: surgical resection of the aneurysm endovascular interventions: coiling, stenting or both

Interventional Therapy

Eligibility Criteria

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

You may qualify if:

• Patients with at least one documented, intracranial subarachnoid aneurysm (cavernous aneurysms are excluded)

You may not qualify if:

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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• University of Alberta: collaborator

Study Sites (6)

University of Alberta Hospital

Edmonton, Alberta, T6G 2R3, Canada

RECRUITING

Daniel Roy

Montreal, Quebec, H2X 3E4, Canada

RECRUITING

Centre Hospitalier Régional Universitaire de Tours

Tours, France

RECRUITING

ASST Ospedale Papa Giovanni XXIII

Bergamo, Italy

RECRUITING

Ospedale Vito Frazzi

Lecce, 73100, Italy

RECRUITING

Ospedale San Carlo Borromeo di Milano

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Aneurysm; Intracranial Aneurysm

Interventions

Microsurgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Micromanipulation; Investigative Techniques

Study Officials

• Tim Darsaut, MD

  Neurosurgeon University of Alberta Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tim Darsaut, MD, MSc

CONTACT

780-407-1440; tdarsaut@ualberta.ca

Jean Raymond, MD

CONTACT

514-890-8000; jean.raymond@umontreal.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: November 5, 2019
• First Posted: November 7, 2019
• Study Start: January 15, 2020
• Primary Completion (Estimated): January 1, 2035
• Study Completion (Estimated): January 1, 2036
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); IT (3); CA (2)