An interventional study of endovascular coiling with any type of currently approved coil (first or second generation) and endovascular stenting with or without coiling. The stent may be any of the currently approved stents for intracranial aneurysms. in Intracranial Aneurysm, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Completed at 5 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-06.
Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Not applicable, Interventional, and Treatment
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.
427 studies on the registry are indexed under Intracranial Aneurysm; 115 are open to participants now.
This study's enrollment of 205 is above the median of 110 across 207 interventional studies indexed under Intracranial Aneurysm.
Browse Intracranial Aneurysm studies →Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 370 studies on the registry; 110 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
endovascular coiling with any type of currently approved coil (first or second generation)
Device: endovascular coiling with any type of currently approved coil (first or second generation)
endovascular stenting with or without coiling. The stent may be any of the currently approved stents for intracranial aneurysms.
Device: endovascular coiling with any type of currently approved coil (first or second generation) · Device: endovascular stenting with or without coiling. The stent may be any of the currently approved stents for intracranial aneurysms.
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
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
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Centre hospitalier de l'Université de Montréal (CHUM)