Stenting in the Treatment of Aneurysm Trial

Not Applicable

Completed

• Conditions: Intracranial Aneurysm
• Interventions: 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.

• Registration Number: NCT01340612
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-20
• Study First Submitted QC: 2011-04-21
• Study First Posted: 2011-04-22
• Study Start: 2011-08-25
• Primary Completion: 2023-01
• Study Completion: 2023-04
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-04
• Last Update Posted: 2023-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 205

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
coiling plus stenting	endovascular stenting with or without coiling. The stent may be any of the currently approved stents for intracranial aneurysms.	endovascular stenting with or without coiling. The stent may be any of the currently approved stents for intracranial aneurysms.
coiling	endovascular coiling with any type of currently approved coil (first or second generation)	endovascular coiling with any type of currently approved coil (first or second generation)
coiling plus stenting	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.

Primary Outcome Measures

Name	Time	Method
Recurrence rate of target aneurysm	12 months	rate of angiographic recurrence

Secondary Outcome Measures

Name	Time	Method
Rate of Procedural complications defined as number of subjects with reported peri-procedural Adverse Events	30 days	Periprocedural Adverse Events is any type of complication or Adverse Event reported during or in the 30 days following the intervention
Incidence of in-stent stenosis defined as the number of subjects with a reduction in the luminal diameter of greater than 50%	12 months	luminal diameter will be evaluated by an independent Core Lab
Overall morbidity and mortality given by the modified Rankin Score	12 months	Overall morbidity and mortality is defined as a change in modified Rankin Score relative to baseline
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	12 months	A morbid event is defined as any Adverse Event of any severity being possibly or probably related to the disease or the treatment

Trial Locations

Locations (5)

CHRU de Brest (Brest University Hospital); 🇫🇷 Brest, France

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada

Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame; 🇨🇦 Montreal, Quebec, Canada

Queen Elizabeth II Health Sciences Centre; 🇨🇦 Halifax, Nova Scotia, Canada