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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
205
Standard procedure for endovascular coiling.Coils may be bare Platinum coils or any so-called second generation coils such as but not restricted to Hydrocoil or Cerecyte
Standard procedure for stenting. Addition of coils to the stent is left to the judgment of the treating physician
University of Alberta Hospital
Edmonton, Alberta, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame
Montreal, Quebec, Canada
Recurrence rate of target aneurysm
rate of angiographic recurrence
Time frame: 12 months
Rate of Procedural complications defined as number of subjects with reported peri-procedural Adverse Events
Periprocedural Adverse Events is any type of complication or Adverse Event reported during or in the 30 days following the intervention
Time frame: 30 days
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
A morbid event is defined as any Adverse Event of any severity being possibly or probably related to the disease or the treatment
Time frame: 12 months
Overall morbidity and mortality given by the modified Rankin Score
Overall morbidity and mortality is defined as a change in modified Rankin Score relative to baseline
Time frame: 12 months
Incidence of in-stent stenosis defined as the number of subjects with a reduction in the luminal diameter of greater than 50%
luminal diameter will be evaluated by an independent Core Lab
Time frame: 12 months
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CHRU de Brest (Brest University Hospital)
Brest, France