Stenting in the Treatment of Aneurysm Trial (STAT)

Centre hospitalier de l'Université de Montréal (CHUM)

Status: Completed

Conditions: Intracranial Aneurysm

Treatments: 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.

Study type: Interventional

Funder types: Other

Identifiers

NCT01340612

CE10.111

Details and patient eligibility

About

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.

Enrollment: 205 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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205 participants in 2 patient groups

coiling

Active Comparator group

Description:

endovascular coiling with any type of currently approved coil (first or second generation)

Treatment:

Device: endovascular coiling with any type of currently approved coil (first or second generation)

coiling plus stenting

Active Comparator group

Description:

endovascular stenting with or without coiling. The stent may be any of the currently approved stents for intracranial aneurysms.

Treatment:

Device: 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)