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Stenting in the Treatment of Aneurysm Trial (STAT)

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ClinicalTrials.gov Identifier: NCT01340612
Recruitment Status : Recruiting
First Posted : April 22, 2011
Last Update Posted : December 15, 2017
Sponsor:
Collaborator:
CHRU de Brest (Brest University Hospital)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment 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  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stenting in the Treatment of Large, Wide-necked or Recurring Intracranial Aneurysms
Actual Study Start Date : August 25, 2011
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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 generation 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 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



Primary Outcome Measures :
  1. Recurrence rate of target aneurysm [ Time Frame: 12 months ]

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

  2. 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 ]
    A morbid event is defined as any Adverse Event of any severity being possibly or probably related to the disease or the treatment

  3. Overall morbidity and mortality defined as a change in modified Rankin Score relative to baseline [ Time Frame: 12 months ]
  4. 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 ]
    luminal diameter will be evaluated by an independent Core Lab



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01340612


Contacts
Contact: Ruby Klink, PhD 1-514-890-8000 ext 26359 ruby.klink@crchum.qc.ca
Contact: Suzanne Nolet 514-890-8000 ext 26359 Suzanne.Nolet@crchum.qc.ca

Locations
Canada, Alberta
University of Alberta Hospital Active, not recruiting
Edmonton, Alberta, Canada
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre Active, not recruiting
Halifax, Nova Scotia, Canada
Canada, Ontario
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada
Contact: Betty Anne Schwarz       baschwarz@Ottawahospital.on.ca   
Principal Investigator: Daniela Iancu, MD         
Canada, Quebec
Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame Recruiting
Montreal, Quebec, Canada, H2L 4M1
Contact: Suzanne Nolet, CCRP    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         
France
CHRU de Brest (Brest University Hospital) Recruiting
Brest, France, 29 609 Brest
Contact: Jean-Christophe Gentric, MD       jcgentric@gmail.com   
Principal Investigator: Jean-Christophe Gentric, MD         
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
CHRU de Brest (Brest University Hospital)
Investigators
Principal Investigator: Jean Raymond, MD Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame

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
First Posted: April 22, 2011    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: December 2017

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