Stenting in the Treatment of Aneurysm Trial (STAT)

  • STATUS
    Recruiting
  • End date
    Jan 19, 2026
  • participants needed
    600
  • sponsor
    Centre hospitalier de l'Université de Montréal (CHUM)
Updated on 19 June 2022

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.

Details
Condition Intracranial Aneurysm
Treatment 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.
Clinical Study IdentifierNCT01340612
SponsorCentre hospitalier de l'Université de Montréal (CHUM)
Last Modified on19 June 2022

Eligibility

Yes No Not Sure

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
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