Grant: Operating Grant
Centre hospitalier de l'Université de Montréal (CHUM)
$514,086.00
The Canadian UnRuptured aneurysm Endovascular versus Surgery trial - The CURES trial
EF 2011-12
Résumé
The treatment of incidentally discovered brain aneurysms that have not yet bled is a vexing problem since the best treatment option remains uncertain. Surgery involves clipping the neck of the aneurysm to prevent blood entry into the aneurysm sac; it requires opening the skull to reach the aneurysm. Endovascular coiling involves introducing metallic coils into the aneurysm sac to occlude it and thus remove it from the brain circulation; the coils are introduced with the help of a catheter to reach the arteries of the brain. There is no scientific proof that one or the other types of treatment, in terms of long term occlusion results or safety profile, is better than the other.
The Canadian UnRuptured Endovascular versus Surgery (CURES) trial is the pilot phase of a randomized trial that aims to compare endovascular coiling to surgical clipping. Randomization ensures that all patients have an equal chance of getting what will turn out to be the best option. It also helps the resolution of the dilemma, by reducing bias in the selection of patients allotted to one or the other treatment.
The CURES pilot trial will recruit 260 patients across Canada, to be followed for one year. The pilot phase of CURES will allow us to:
1) determine whether there is a significant difference in the number of treatment failures between the groups of patients treated with coiling compared to clipping. Treatment failure is defined as: brain hemorrhage following treatment, failure to totally occlude the aneurysm during treatment, or recurrence of the aneurysm within the first year;
2) provide an estimate of morbidity and mortality values that will provide randomized data to guide the design of the pivotal portion of the study, which will study clinical outcomes.
3) determine feasibility of a larger (estimated 1000 patient) international trial.
Programme
Operating Grant
Emplacement
Quebec, Canada
Type de bénéficiaire
Not-for-profit organization or charity
Type
Grant
Source
CIHR Funding Decisions Database
Tel que publié
Id
239366
Name
Raymond Jean
Region
Québec
Country
Canada
Orgtype
Institution Paid; Research Institution
Instname2
Circulatory and Respiratory Health
Theme2
Clinical
Prcname2
Clinical Investigation - D: Cardiovascular Systems
Projecttitle
The Canadian UnRuptured aneurysm Endovascular versus Surgery trial - The CURES trial
Programtype2
Operating Grants
Orgnameinp2
Centre hospitalier de l'Université de Montréal (CHUM)
Cihramount2
$514,086
Cihrequipment2
$0
Programname2
Operating Grant
Keyworddelim
Endovascular Coiling; Intracranial Hemorrhage; Randomized Controlled Trial; Recurrence; Surgical Clipping; Unruptured Aneurysm
Abstract
The treatment of incidentally discovered brain aneurysms that have not yet bled is a vexing problem since the best treatment option remains uncertain. Surgery involves clipping the neck of the aneurysm to prevent blood entry into the aneurysm sac; it requires opening the skull to reach the aneurysm. Endovascular coiling involves introducing metallic coils into the aneurysm sac to occlude it and thus remove it from the brain circulation; the coils are introduced with the help of a catheter to reach the arteries of the brain. There is no scientific proof that one or the other types of treatment, in terms of long term occlusion results or safety profile, is better than the other.
The Canadian UnRuptured Endovascular versus Surgery (CURES) trial is the pilot phase of a randomized trial that aims to compare endovascular coiling to surgical clipping. Randomization ensures that all patients have an equal chance of getting what will turn out to be the best option. It also helps the resolution of the dilemma, by reducing bias in the selection of patients allotted to one or the other treatment.
The CURES pilot trial will recruit 260 patients across Canada, to be followed for one year. The pilot phase of CURES will allow us to:
1) determine whether there is a significant difference in the number of treatment failures between the groups of patients treated with coiling compared to clipping. Treatment failure is defined as: brain hemorrhage following treatment, failure to totally occlude the aneurysm during treatment, or recurrence of the aneurysm within the first year;
2) provide an estimate of morbidity and mortality values that will provide randomized data to guide the design of the pivotal portion of the study, which will study clinical outcomes.
3) determine feasibility of a larger (estimated 1000 patient) international trial.
Competitiondate
201109
Approvedterm2
5 yrs 0 mth
Pinamesdelim
Raymond, Jean
Approvedterm
5 ans 0 mois
Cihrcontribution2
~ $514,086~ $0~