Stenting in the Treatment of Aneurysm Trial (STAT)

• Rate of Procedural complications defined as number of subjects with reported peri-procedural Adverse Events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  Periprocedural Adverse Events is any type of complication or Adverse Event reported during or in the 30 days following the intervention
• 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 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  A morbid event is defined as any Adverse Event of any severity being possibly or probably related to the disease or the treatment
• Overall morbidity and mortality defined as a change in modified Rankin Score relative to baseline [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
• Incidence of in-stent stenosis defined as the number of subjects with a reduction in the luminal diameter of greater than 50% [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  luminal diameter will be evaluated by an independant Core Lab

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.

• Device: endovascular coiling with any type of currently approved coil (first or second generation)
  Standard procedure for endovascular coiling.Coils may be bare Platinum coils or any so-called second genration coils such as but not restricted to Hydrocoil or Cerecyte
• Device: endovascular stenting with or without coiling. The stent may be any of the currently approved stents for intracranial aneurysms.
  Standard procedure for stenting. Addition of coils to the stent is left to the judgment of the treating physician

• Active Comparator: coiling
  Intervention: Device: endovascular coiling with any type of currently approved coil (first or second generation)
• Active Comparator: coiling plus stenting
  Interventions:

  • 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.

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