Stenting in the Treatment of Aneurysm Trial

Study Overview
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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.

Official Title
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Stenting in the Treatment of Large, Wide-necked or Recurring Intracranial Aneurysms

Conditions
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Intracranial Aneurysm

Intervention / Treatment
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* 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.


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: coiling<br>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)<br>* 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<br>|
| Active Comparator: coiling plus stenting<br>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)<br>* 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<br>Device: endovascular stenting with or without coiling. The stent may be any of the currently approved stents for intracranial aneurysms.<br>* Standard procedure for stenting. Addition of coils to the stent is left to the judgment of the treating physician<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate of target aneurysm | rate of angiographic recurrence | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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large aneurysm, wide-necked aneurysm, recurring aneurysm