Trial on Endovascular Aneurysm Management

Status Terminated

Clinical Trial Summary

The management of patients with unruptured aneurysms is controversial. Patients with unruptured aneurysms may suffer intracranial hemorrhage, but the incidence of this event is still debated. Endovascular treatment can prevent rupture, but involves immediate risks; furthermore, successful treatment does not eliminate all risks. A randomized trial may be the best way to demonstrate the potential benefits of endovascular over conservative management of unruptured aneurysms.

Clinical Trial Description

This study is designed as a pragmatic trial. All candidates for endovascular treatment of one or more unruptured intracranial aneurysms will be offered to participate. Unruptured aneurysms may be recently discovered or prevalent. If they accept, subjects will be randomized to one of the two arms of the trial: Conservative management (Observation) or Endovascular treatment. Both groups will be advised to obtain medical treatment for hypertension if necessary and will receive counselling for behavioural risk factor modelling (smoking or excessive drinking) when indicated. A non-invasive (MRA or CTA) or catheter angiogram and a baseline CT-scan or MRI of the brain are required to enter the study. These studies should demonstrate the unequivocal presence of a saccular aneurysm >=3 mm treatable by endovascular methods. A catheter angiogram is required if there is doubt. Imaging studies will be reviewed centrally. Both treatments will be standardized. Patients will be followed similarly for a minimum of 10 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00537134
Study type	Interventional
Source	Centre hospitalier de l'Université de Montréal (CHUM)
Contact
Status	Terminated
Phase	N/A
Start date	April 2006
Completion date	July 2009

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See also
Status	Clinical Trial	Phase
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Completed	`NCT01716117` - Safety and Effectiveness of an Intracranial Aneurysm Embolization System for Treating Large or Giant Wide Neck Aneurysms	N/A
Completed	`NCT04553549` - Safety and Feasibility of the Infinity Catheter for Radial Access
Completed	`NCT04439760` - Superior Cervical Ganglion Block, Transcranial Doppler	N/A
Completed	`NCT01975233` - WEB French Observatory of the WEB Aneurysm Embolization System
Terminated	`NCT01557036` - Aneurysm Study of Pipeline in an Observational Registry	N/A
Completed	`NCT02435823` - Safety Study of the PulseRider® in Patients Undergoing Treatment for Bifurcation Intracranial Aneurysms	N/A
Completed	`NCT03844334` - CLinical EValuation of WEB 0.017 Device in Intracranial AneuRysms
Active, not recruiting	`NCT03852680` - Current Treatment Modalities for Wide Necked Intracranial Aneurysms	N/A
Completed	`NCT01444664` - Aneurysm Wall Histology Registry	Phase 4
Recruiting	`NCT03936647` - The RISE Trial: A Randomized Trial on Intra-Saccular Endobridge Devices	N/A
Completed	`NCT02687607` - CLARYS: CLinical Assessment of WEB® Device in Ruptured aneurYSms
Withdrawn	`NCT02037932` - Hydrogel Balloon Assisted Intracranial Aneurysm Coiling Registry	Phase 4
Recruiting	`NCT05317169` - Aneurysm Genetic Risk in Patients With QIB Changes

Trial on Endovascular Aneurysm Management — TEAM

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms