Stenting in the Treatment of Aneurysm Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 4 March 2013
• Main ID: NCT01340612
• Date of registration: 20/04/2011
• Primary sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Public title: Stenting in the Treatment of Aneurysm Trial STAT
• Scientific title: Stenting in the Treatment of Large, Wide-necked or Recurring Intracranial Aneurysms
• Date of first enrolment: April 2011
• Target sample size: 600
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01340612
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Canada

Contacts

• Name: Ruby Klink, PhD

• Name: Jean Raymond, MD
• Affiliation: Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Intracranial Aneurysm

Intervention(s)

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.

Primary Outcome(s)

Recurrence rate of target aneurysm [Time Frame: 12 months]

Secondary Outcome(s)

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]

Overall morbidity and mortality defined as a change in modified Rankin Score relative to baseline [Time Frame: 12 months]

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]

Rate of Procedural complications defined as number of subjects with reported peri-procedural Adverse Events [Time Frame: 30 days]

Secondary ID(s)

CE10.111

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Centre de Recherche du Centre Hospitalier de l'Université de Montréal