NCT04155606 Comprehensive Aneurysm Management Trial

Eligibility & Interventions

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 2,000 participants in total. It began in 2020-01-15 with a primary completion date of 2035-01.

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. 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

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

Contact & Investigator

Frequently Asked Questions