Stenting in the Treatment of Aneurysm Trial (STAT)

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

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.

Study Overview

• Status: Completed
• Conditions: Intracranial Aneurysm
• Intervention / Treatment: 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.

• Study Type: Interventional
• Enrollment (Actual): 205
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ruby Klink, PhD; Phone Number: 26359 1-514-890-8000; Email: ruby.klink@crchum.qc.ca

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada
      • University of Alberta Hospital
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
      • Queen Elizabeth II Health Sciences Centre
  • Ontario
    • Ottawa, Ontario, Canada
      • The Ottawa Hospital
  • Quebec
    • Montreal, Quebec, Canada, H2L 4M1
      • Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame
• France
  • Brest, France, 29 609 Brest
    • CHRU de Brest (Brest University Hospital)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: coiling; 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); 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
Active Comparator: coiling plus stenting; 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); 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; 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

What is the study measuring?

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
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
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

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Collaborators: University Hospital, Brest
• Investigators: Principal Investigator: Jean Raymond, MD, Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2011
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): April 1, 2023

Study Registration Dates

• First Submitted: April 20, 2011
• First Submitted That Met QC Criteria: April 21, 2011
• First Posted (Estimated): April 22, 2011

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 4, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: large aneurysm; wide-necked aneurysm; recurring aneurysm
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: CE10.111