Stenting in the Treatment of Aneurysm Trial

Intracranial Aneurysm Clinical Trial

— STAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01340612
• Other study ID #: CE10.111
• Status: Completed
• Phase: N/A
• Start date: August 25, 2011
• Est. completion date: April 2023

Study information

• Verified date: July 2023
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: April 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

Device:
• 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
• 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

Locations

Country	Name	City	State
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia
Canada	Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame	Montreal	Quebec
Canada	The Ottawa Hospital	Ottawa	Ontario
France	CHRU de Brest (Brest University Hospital)	Brest

Sponsors (2)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)	University Hospital, Brest

Countries where clinical trial is conducted

Canada,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence rate of target aneurysm	rate of angiographic recurrence	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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