Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comprehensive Aneurysm Management Trial (CAM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04155606
Recruitment Status : Not yet recruiting
First Posted : November 7, 2019
Last Update Posted : April 17, 2020
Sponsor:
Collaborator:
University of Alberta
Information provided by (Responsible Party):
Jean Raymond, Centre hospitalier de l'Université de Montréal (CHUM)

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 prinicpal questions to be addressed are :

  1. do patients with UIAs, considered for curative treatments, have a better long-term clinical outcome with active treatment or conservative management?
  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.

This study is designed as a pragmatic, comprehensive way to address the unruptured aneurysm clinical dilemma, combining large simple RCTs whenever patients are judged eligible for more than one management option, or otherwise a registry of each option. All patients with one or more UIAs will be eligible for participation in either a registry or one of the trials. Patients will be followed for 10 years according to a standard of car follow-up schedule.

The primary outcome is survival without neurological dependency (mRS<3) at 10 years.

The secondary outcomes are:

  1. the incidence of SAH during follow-up and related morbidity and mortality;
  2. the morbidity and mortality related to endovascular or surgical treatment of the UIA at one year;
  3. overall mortality at 1, 5 and 10 years;
  4. overall morbidity (mRS>2) at 1, 5 and 10 years;
  5. length of hospitalization;
  6. discharge to location other than home

Condition or disease Intervention/treatment Phase
Saccular Aneurysm Intracranial Aneurysm Unruptured Cerebral Aneurysm Device: microsurgery; endovascular interventions Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Comprehensive Aneurysm Management Trial
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : January 2035
Estimated Study Completion Date : January 2036

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Interventional Therapy
Neurosurgery or Endovascular procedure
Device: microsurgery; endovascular interventions
microsurgery: surgical resection of the aneurysm endovascular interventions: coiling, stenting or both

No Intervention: Conservative Management
Monitoring with pharmacological therapy if need arises.



Primary Outcome Measures :
  1. Survival without neurological dependency [ Time Frame: 10 years ]
    Number of patients without neurological dependency. Neurological dependency is defined as an outcome with a modified Rankin Score greater or equal to 3


Secondary Outcome Measures :
  1. Sub-arachnoid hemorrhage (SAH) [ Time Frame: 10 years ]
    Number of patients with an incidence of SAH and related morbidity and mortality

  2. morbi/mortality related to interventions [ Time Frame: 1 year ]
    Number of patients with Morbidity or Mortality related to microsurgery of endovascular procedures

  3. Overall mortality [ Time Frame: 1, 5 and 10 years ]
    Number of patients dead from any cause

  4. Overall morbidity [ Time Frame: 1, 5 and 10 years ]
    Number of patients with a modified Rankin Score greater or equal to 3

  5. Length of hospitalization [ Time Frame: 10 years ]
    Number of days spent in hospital for intervention

  6. Discharge location other than Home [ Time Frame: 10 years ]
    Number of patients discharged to a location other than home after the intervention



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155606


Contacts
Layout table for location contacts
Contact: Tim Darsaut, MD, MSc 780-407-1440 tdarsaut@ualberta.ca
Contact: Jean Raymond, MD 514-890-8000 ext 27235 jean.raymond@umontreal.ca

Locations
Layout table for location information
Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2R3
Contact: Tim Darsaut, MD, MSc    780-407-1440    tdarsaut@ualberta.ca   
Principal Investigator: Tim Darsaut, MD, MSc         
Canada, Quebec
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada, H2X 3E4
Contact: Jean Raymond, MD    514-890-8000 ext 27235    jean.raymond@umontreal.ca   
Contact: Guylaine Gevry, BSc    514-890-8000 ext 27235    guylaine.gevry.chum@ssss.gouv.qc.ca   
Principal Investigator: Jean Raymond, MD         
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
University of Alberta
Investigators
Layout table for investigator information
Principal Investigator: Tim Darsaut, MD Neurosurgeon University of Alberta Health
Layout table for additonal information
Responsible Party: Jean Raymond, Principal Investigator (Interventional Neuroradiologist), Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT04155606    
Other Study ID Numbers: 2020-9600
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jean Raymond, Centre hospitalier de l'Université de Montréal (CHUM):
Unruptured Intracranial Aneurysm
Endovascular treatment
Surgical treatment
Conservative management
Additional relevant MeSH terms:
Layout table for MeSH terms
Intracranial Aneurysm
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases