Comprehensive Aneurysm Management Trial (CAM)
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|ClinicalTrials.gov Identifier: NCT04155606|
Recruitment Status : Not yet recruiting
First Posted : November 7, 2019
Last Update Posted : April 17, 2020
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 :
- do patients with UIAs, considered for curative treatments, have a better long-term clinical outcome with active treatment or conservative management?
- 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:
- the incidence of SAH during follow-up and related morbidity and mortality;
- the morbidity and mortality related to endovascular or surgical treatment of the UIA at one year;
- overall mortality at 1, 5 and 10 years;
- overall morbidity (mRS>2) at 1, 5 and 10 years;
- length of hospitalization;
- 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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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
- Sub-arachnoid hemorrhage (SAH) [ Time Frame: 10 years ]Number of patients with an incidence of SAH and related morbidity and mortality
- morbi/mortality related to interventions [ Time Frame: 1 year ]Number of patients with Morbidity or Mortality related to microsurgery of endovascular procedures
- Overall mortality [ Time Frame: 1, 5 and 10 years ]Number of patients dead from any cause
- Overall morbidity [ Time Frame: 1, 5 and 10 years ]Number of patients with a modified Rankin Score greater or equal to 3
- Length of hospitalization [ Time Frame: 10 years ]Number of days spent in hospital for intervention
- Discharge location other than Home [ Time Frame: 10 years ]Number of patients discharged to a location other than home after the intervention
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
|Contact: Tim Darsaut, MD, MScfirstname.lastname@example.org|
|Contact: Jean Raymond, MD||514-890-8000 ext email@example.com|
|University of Alberta Hospital|
|Edmonton, Alberta, Canada, T6G 2R3|
|Contact: Tim Darsaut, MD, MSc 780-407-1440 firstname.lastname@example.org|
|Principal Investigator: Tim Darsaut, MD, MSc|
|Centre hospitalier de l'Université de Montréal (CHUM)|
|Montreal, Quebec, Canada, H2X 3E4|
|Contact: Jean Raymond, MD 514-890-8000 ext 27235 email@example.com|
|Contact: Guylaine Gevry, BSc 514-890-8000 ext 27235 firstname.lastname@example.org|
|Principal Investigator: Jean Raymond, MD|
|Principal Investigator:||Tim Darsaut, MD||Neurosurgeon University of Alberta Health|