Clinical trial NCT01340612: Stenting in the Treatment of Aneurysm Trial
Official title: Stenting in the Treatment of Large, Wide-necked or Recurring Intracranial Aneurysms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracranial Aneurysm
Keywords: large aneurysm
wide-necked aneurysm
recurring aneurysm
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: University Hospital, Brest
First posted: 2011-04-22
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The STAT trial aims at comparing coiling versus coiling plus stenting in patients with aneurysms prone to recurrence, that is large aneurysms or recurring aneurysms after previous coiling or wide-necked aneurysms. The primary hypothesis is that the use of stenting in addition to coiling decreases the recurrence rate from 33% to 20% at 12 months as compared to coiling alone.


Eligibility criteria: Inclusion Criteria:

* All patients presenting at least one aneurysm candidate for coiling, with large (≥10mm), wide-necked (\>4mm), or recurrent lesions after coiling (but not stenting) and judged by the neurovascular team to require elective treatment provided that this single lesion, and no other aneurysm, will be treated during the endovascular session to be the object of the trial
* The anatomy of the lesion is such that endovascular treatment is judged possible with or without stenting
* The endovascular physician is a priori content to use either type of technique
* The patient has not previously been randomized into the trial
* Treatment is elective
* Patient is 18 or older
* Life expectancy is more than 2 years
* Patient has given fully informed consent and has signed consent form

Exclusion Criteria:

* Other aneurysms requiring treatment during the same session
* Patients with associated cerebral arteriovenous malformations
* Patients with recently ruptured aneurysms
* When parent vessel occlusion is the primary intent of the procedure
* Any absolute contraindication to endovascular treatment, angiography, or anesthesia such as severe allergies to contrast or medications, including ASA and Clopidogrel
* Patients with recurring, previously stented aneurysms

Primary outcomes:
measure: Recurrence rate of target aneurysm
timeFrame: 12 months
Secondary outcomes:
measure: Rate of Procedural complications defined as number of subjects with reported peri-procedural Adverse Events
timeFrame: 30 days
measure: Rate of mortality and morbidity defined as the number of subjects with a disabling neurological events as measured by a modified Rankin Score greater than 2 during the follow-up period
timeFrame: 12 months
measure: Overall morbidity and mortality given by the modified Rankin Score
timeFrame: 12 months
measure: Incidence of in-stent stenosis defined as the number of subjects with a reduction in the luminal diameter of greater than 50%
timeFrame: 12 months
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame
state: Quebec
city: Brest
country: France
facility: CHRU de Brest (Brest University Hospital)
Study officials:
affiliation: Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame
name: Jean Raymond, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Naggara O, Darsaut T, Trystram D, Tselikas L, Raymond J. Unruptured intracranial aneurysms: why we must not perpetuate the impasse for another 25 years. Lancet Neurol. 2014 Jun;13(6):537-8. doi: 10.1016/S1474-4422(14)70091-2. No abstract available.
citation: Darsaut TE, Raymond J; STAT Collaborative Group. The design of the STenting in Aneurysm Treatments (STAT) trial. J Neurointerv Surg. 2012 May;4(3):178-81. doi: 10.1136/neurintsurg-2011-010065. Epub 2011 Jun 23.