Stenting in the Treatment of Aneurysm Trial

NCT01340612 | Completed DMC

• 1 other identifier: CE10.111
• Study Type: interventional
• Target: 205
• Locations: 2 countries
• Sites: 5

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.

Conditions

Intracranial Aneurysm

Keywords

large aneurysm; wide-necked aneurysm; recurring aneurysm

Outcome Measures

Primary Outcomes (1)

• Recurrence rate of target aneurysm

  rate of angiographic recurrence

  12 months

Secondary Outcomes (4)

• Rate of Procedural complications defined as number of subjects with reported peri-procedural Adverse Events

  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

  12 months

• Overall morbidity and mortality given by the modified Rankin Score

  12 months

• Incidence of in-stent stenosis defined as the number of subjects with a reduction in the luminal diameter of greater than 50%

  12 months

Study Arms (2)

coiling

ACTIVE COMPARATOR

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)

coiling plus stenting

ACTIVE COMPARATOR

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); Device: endovascular stenting with or without coiling. The stent may be any of the currently approved stents for intracranial aneurysms.

Interventions

endovascular coiling with any type of currently approved coil (first or second generation) DEVICE

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

coiling; coiling plus stenting

endovascular stenting with or without coiling. The stent may be any of the currently approved stents for intracranial aneurysms. DEVICE

Standard procedure for stenting. Addition of coils to the stent is left to the judgment of the treating physician

coiling plus stenting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• University Hospital, Brest: collaborator

Study Sites (5)

University of Alberta Hospital

Edmonton, Alberta, Canada

Location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, Canada

Location

Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame

Montreal, Quebec, H2L 4M1, Canada

Location

CHRU de Brest (Brest University Hospital)

Brest, 29 609 Brest, France

Location

Related Publications (2)

• 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.

  PMID: 24849854 DERIVED

• 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.

  PMID: 21990519 DERIVED

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jean Raymond, MD

  Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2011
• First Posted: April 22, 2011
• Study Start: August 25, 2011
• Primary Completion: January 1, 2023
• Study Completion: April 1, 2023
• Last Updated: July 6, 2023

Record last verified: 2023-07

Locations

CA (4); FR (1)