Stenting in the Treatment of Aneurysm Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-25

Study Completion Date

2023-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Intracranial Aneurysm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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coiling

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

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

coiling plus stenting

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

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

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

Intervention Type DEVICE

Standard procedure for stenting. Addition of coils to the stent is left to the judgment of the treating physician

Interventions

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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 generation coils such as but not restricted to Hydrocoil or Cerecyte

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No