Intracranial AneurysmSTATNCT01340612
Stenting in the Treatment of Aneurysm Trial
A study testing endovascular coiling with any type of currently approved coil (first or second generation) and endovascular stenting with or without coiling. The stent may be any of the currently approved stents for intracranial aneurysms. in people with Intracranial Aneurysm, run by Centre hospitalier de l'Université de Montréal (CHUM) at 5 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- endovascular coiling with any type of currently approved coil (first or second generation) and endovascular stenting with or without coiling. The stent may be any of the currently approved stents for intracranial aneurysms.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 25 Aug 2011to Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Canada4 sites
University of Alberta Hospital
Edmonton, Alberta
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia
Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame
Montreal, Quebec, H2L 4M1
The Ottawa Hospital
Ottawa, Ontario
About this study
Official title: Stenting in the Treatment of Large, Wide-necked or Recurring Intracranial Aneurysms
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
- Being tested
- endovascular coiling with any type of currently approved coil (first or second generation), endovascular stenting with or without coiling. The stent may be any of the currently approved stents for intracranial aneurysms.
- Keywords
- large aneurysm, wide-necked aneurysm, recurring aneurysm
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| coiling | Active comparator | endovascular coiling with any type of currently approved coil (first or second generation) Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate of target aneurysm
rate of angiographic recurrence
Measured: 12 months
Secondary outcomes (4)
Rate of Procedural complications defined as number of subjects with reported peri-procedural Adverse Events
Periprocedural Adverse Events is any type of complication or Adverse Event reported during or in the 30 days following the intervention
Measured: 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
A morbid event is defined as any Adverse Event of any severity being possibly or probably related to the disease or the treatment
Measured: 12 months
Overall morbidity and mortality given by the modified Rankin Score
Overall morbidity and mortality is defined as a change in modified Rankin Score relative to baseline
Measured: 12 months
Incidence of in-stent stenosis defined as the number of subjects with a reduction in the luminal diameter of greater than 50%
luminal diameter will be evaluated by an independent Core Lab
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2011 (estimated)
- Study start25 Aug 2011
- Primary completionJan 2023
- Study completionApr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Brest
- Responsible party
- Sponsor
- Investigators
- Jean Raymond, MD, Principal investigator, Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01340612
- Sponsor's protocol ID
- CE10.111
- Acronym
- STAT
- Status last verified
- Jul 2023
- First submitted
- 20 Apr 2011
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24849854Darsaut 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.
PubMed 21990519
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stenting in the Treatment of Large, Wide-necked or Recurring Intracranial Aneurysms
- ClinicalTrials.gov ID
- NCT01340612
- Acronym / sponsor ID
- STAT / CE10.111
- Conditions
- Intracranial Aneurysm
- Keywords
- large aneurysm, wide-necked aneurysm, recurring aneurysm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- University Hospital, Brest
- Study start
- 25 Aug 2011 (actual)
- Primary completion
- Jan 2023 (actual)
- Study completion
- Apr 2023 (actual)
- First posted
- 22 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| coiling | Active comparator | Device: endovascular coiling with any type of currently approved coil (first or second generation)endovascular coiling with any type of currently approved coil (first or second generation) |
| coiling plus stenting | Active comparator | 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.endovascular stenting with or without coiling. The stent may be any of the currently approved stents for intracranial aneurysms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | coiling, coiling plus stenting |
| 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 | Device | coiling plus stenting |
Primary outcome
Recurrence rate of target aneurysm
Time frame: 12 months
rate of angiographic recurrence
4 secondary outcomes
Rate of Procedural complications defined as number of subjects with reported peri-procedural Adverse Events
Time frame: 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
Time frame: 12 months
Overall morbidity and mortality given by the modified Rankin Score
Time frame: 12 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Derived from this study: PubMed 24849854Naggara 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.
- Derived from this study: PubMed 21990519Darsaut 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Raymond, MD principal investigator
Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endovascular coiling with any type of currently approved coil (first or second generation) and endovascular stenting with or without coiling. The stent may be any of the currently approved stents for intracranial aneurysms. in people with Intracranial Aneurysm, run by Centre hospitalier de l'Université de Montréal (CHUM) at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate of target aneurysm (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01340612, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.