Text Size

Stenting in the Treatment of Aneurysm Trial (STAT)

This study is currently recruiting participants.
Verified February 2013 by Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor:
Collaborator:
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT01340612
First received: April 20, 2011
Last updated: February 26, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Intracranial Aneurysm
 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.
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Stenting in the Treatment of Large, Wide-necked or Recurring Intracranial Aneurysms

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:
  • Recurrence rate of target aneurysm [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of Procedural complications defined as number of subjects with reported peri-procedural Adverse Events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Periprocedural Adverse Events is any type of complication or Adverse Event reported during or in the 30 days following the intervention

  • 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 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    A morbid event is defined as any Adverse Event of any severity being possibly or probably related to the disease or the treatment

  • Overall morbidity and mortality defined as a change in modified Rankin Score relative to baseline [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Incidence of in-stent stenosis defined as the number of subjects with a reduction in the luminal diameter of greater than 50% [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    luminal diameter will be evaluated by an independant Core Lab


Estimated Enrollment: 600
Study Start Date: April 2011
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: coiling 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 genration coils such as but not restricted to Hydrocoil or Cerecyte
Active Comparator: coiling plus stenting 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 genration 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01340612

Contacts
Contact: Ruby Klink, PhD 1-514-890-8000 ext 25245 ruby.klink@crchum.qc.ca

Locations
Canada, Alberta
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada
Contact: Tim Darsaut, MD, MSc         Tim.Darsaut@albertahealthservices.ca    
Principal Investigator: Tim - Darsaut, MD, MSc            
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre Not yet recruiting
Halifax, Nova Scotia, Canada
Contact: Judith - Jarrett, RN CCRP         judith.jarett@cdha.nshealth.ca    
Principal Investigator: Ian Fleetwood, MD            
Canada, Quebec
Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame Recruiting
Montreal, Quebec, Canada, H2L 4M1
Contact: Suzanne Nolet, BSc     1-514-890-8000 ext 26359     suzanne.nolet@crchum.qc.ca    
Principal Investigator: Jean Raymond, MD            
Sub-Investigator: Daniel Roy, MD            
Sub-Investigator: Alain Weill, MD            
Sub-Investigator: François Guilbert, MD            
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Investigators
Principal Investigator: Jean Raymond, MD Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame
  More Information

No publications provided by Centre hospitalier de l'Université de Montréal (CHUM)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT01340612     History of Changes
Other Study ID Numbers: CE10.111
Study First Received: April 20, 2011
Last Updated: February 26, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
large aneurysm
wide-necked aneurysm
recurring aneurysm

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 21, 2013