Health TrialsbyHealthPanel

Comprehensive Aneurysm Management Trial

ConditionsSaccular AneurysmIntracranial AneurysmUnruptured Cerebral Aneurysm
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre hospitalier de l'Université de Montréal (CHUM)

About this trial

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. 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients with any intracranial hemorrhage, including SAH, within the previous 30 days

Patients with AVM-associated aneurysms

Patients unable to give informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • microsurgery; endovascular interventions

    Device

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

Treatment groups

2,000 Participants
are divided into 2 treatment groups
Group A: Interventional TherapyActive comparator 1 intervention
Group B: Conservative ManagementNo intervention 0 interventions

Trial outcomes

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

Time frame
10 years

Secondary outcomes

1

Sub-arachnoid hemorrhage (SAH)

Number of patients with an incidence of SAH and related morbidity and mortality

Time frame
10 years
2

morbi/mortality related to interventions

Number of patients with Morbidity or Mortality related to microsurgery of endovascular procedures

Time frame
1 year
3

Overall mortality

Number of patients dead from any cause

Time frame
1, 5 and 10 years
4

Overall morbidity

Number of patients with a modified Rankin Score greater or equal to 3

Time frame
1, 5 and 10 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre hospitalier de l'Université de Montréal (CHUM)

Lead sponsor

University of Alberta

Collaborator

Source ClinicalTrials.gov
Apply now