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| Name | Class |
|---|---|
| University Hospital, Brest | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| coiling | Active Comparator | endovascular coiling with any type of currently approved coil (first or second generation) |
|
| coiling plus stenting | Active Comparator | endovascular stenting with or without coiling. The stent may be any of the currently approved stents for intracranial aneurysms. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endovascular coiling with any type of currently approved coil (first or second generation) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence rate of target aneurysm | rate of angiographic recurrence | 12 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean Raymond, MD | Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta Hospital | Edmonton | Alberta | Canada | |||
| Queen Elizabeth II Health Sciences Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24849854 | Derived | Naggara O, Darsaut T, Trystram D, Tselikas L, Raymond J. Unruptured intracranial aneurysms: why we must not perpetuate the impasse for another 25 years. Lancet Neurol. 2014 Jun;13(6):537-8. doi: 10.1016/S1474-4422(14)70091-2. No abstract available. | |
| 21990519 | Derived | Darsaut TE, Raymond J; STAT Collaborative Group. The design of the STenting in Aneurysm Treatments (STAT) trial. J Neurointerv Surg. 2012 May;4(3):178-81. doi: 10.1136/neurintsurg-2011-010065. Epub 2011 Jun 23. |
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| endovascular stenting with or without coiling. The stent may be any of the currently approved stents for intracranial aneurysms. | Device | Standard procedure for stenting. Addition of coils to the stent is left to the judgment of the treating physician |
|
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 |
| Halifax |
| Nova Scotia |
| Canada |
| The Ottawa Hospital | Ottawa | Ontario | Canada |
| Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame | Montreal | Quebec | H2L 4M1 | Canada |
| CHRU de Brest (Brest University Hospital) | Brest | 29 609 Brest | France |
| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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