Skip to main content
OpenTrials
Completed

NCT Number: NCT01340612

Stenting in the Treatment of Aneurysm Trial

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta Hospital, Edmonton, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Recurrence rate of target aneurysm

    Time frame: 12 months

    rate of angiographic recurrence

Secondary outcomes

  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 given by the modified Rankin Score

    Time frame: 12 months

    Overall morbidity and mortality is defined as a change in modified Rankin Score relative to baseline

  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

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Collaborators

  • University Hospital, Brest

Registry information

Official study title

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

Acronym: STAT

Important dates

Study start
2011
Primary completion
2023
Study completion
2023
First posted
Apr 22, 2011
Registry last updated
Jul 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.