Intracranial AneurysmEVIDENCENCT01811134
Flow Diverter Stent for Endovascular Treatment of Unruptured Saccular Wide-necked Intracranial Aneurysms
A study testing PIPELINE flow diverter stent and Coils, with or without expendable stent in people with Intracranial Aneurysm, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Unruptured saccular intracranial aneurysms larger than 7 mm can be treated with endovascular occlusion using detachable coils, with or without expendable stent assistance. A new endovascular technique has recently been developed, using flow diverter stents without associated coils. 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?
- PIPELINE flow diverter stent and Coils, with or without expendable stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2012to Mar 2020
- 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
- Patient's age ≥ 18 years old
- Unruptured saccular intracranial aneurysm diagnosed by angiography or CT angiography or MR angiography, located in the intra-dural area, with a neck diameter between 4 and 10 mm, with a sac diameter between 7 mm and 20 mm, with a ratio "dome/nek" greater than 1, and with a diameter of the parent artery between 2 and 5 mm.
- No prior treatment of the aneurysm
- Agreement for participating in the study and informed consent signed by the patient
- Patient affiliated to a social security scheme
Who cannot join
- Patient's age < 18 years old
- Adult patient protected by law
- Contraindications to the endovascular procedure
- Contraindications to antiplatelet or anticoagulant treatment
- Prior treatment of the aneurysm
- Presence of an arteriovenous malformation
Show all 11Show fewer
- Extradural location of the aneurysm
- Fusiform aneurysm
- Active bacterial infection (clinical signs)
- Intracranial hemorrhage from aneurysm in the previous month
- Pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Randomized Study for Medico-economic Evaluation of Embolization With Flow Diverter Stent in the Endovascular Treatment of Unruptured Saccular Wide-necked Intracranial Aneurysms
Unruptured saccular intracranial aneurysms larger than 7 mm can be treated with endovascular occlusion using detachable coils, with or without expendable stent assistance. A new endovascular technique has recently been developed, using flow diverter stents without associated coils. Clinical results already published are encouraging but have to be confirmed. Furthermore, these medical devices are expensive in comparison to the coiling strategy. The purpose of this study is to compare the clinical efficacy, safety, and cost-effectiveness of endovascular coiling and endovascular flow diversion for unrupted saccular intracranial aneurysms.
Read the detailed description
Main Outcome Measure: Percentage of patients with an aneurysm with complete occlusion, defined as the absence of visible blood flow to the consideration of angiography performed 12 months post-endovascular intervention.
- Conditions
- Intracranial Aneurysm
- Being tested
- PIPELINE flow diverter stent, Coils, with or without expendable stent
- Keywords
- endovascular procedure; flow diverter stent
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIPELINE flow diverter stentDevice
endovascular procedure using the medical device PIPELINE
Coils, with or without expendable stentDevice
endovascular embolization procedure using microspires, with the possibility of using a balloon temporary and / or implantation of a stent complementary intracranial before implementation of microspires
| Study group | Role | What they receive |
|---|---|---|
| PIPELINE flow diverter stent | Experimental | flow diverter stent Receives: Device: PIPELINE flow diverter stent; Device: Coils, with or without expendable stent |
| Coils, with or without expendable stent | Active comparator | Coils Receives: Device: PIPELINE flow diverter stent; Device: Coils, with or without expendable stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with complete occlusion of the treated aneurysm, defined as the absence of visible blood flow on angiography performed 12 months after endovascular procedure.
Measured: 12 months
Secondary outcomes (17)
Occurrence of a death during or after endovascular procedure
Measured: hospitalization for the endovascular procedure, up to 7 days
Occurrence of a death whatever the cause
Measured: 24 months
Occurrence of a death due to aneurysm rupture
Measured: 24 months
Occurrence of an intracranial hemorrhagic from rupture of the aneurysm
Measured: 24 months
Occurrence of an ischemic stroke due to thrombosis
Measured: 24 months
Occurrence of a non-cerebral bleeding
Measured: 24 months
Rate of patients with neurological deficits by mass effect
Measured: hospitalization for the endovascular procedure, an expected average of 1 hour; 3 months, 6 months and 12 months post-intervention
Retreatment of the aneurysm
Measured: 24 months
Rate of technical complications
Measured: Endovascular procedure an expected average of 1 hour
Rate of thromboembolic complications, intraoperative ruptures, complications at the puncture site, or others
Measured: Endovascular procedure an expected average of 1 hour
Rate of correct placement of flow diverter stents, according to the investigator
Measured: Endovascular procedure an expected average of 1 hour
mean duration of irradiation related to angiography
Measured: Endovascular procedure an expected average of 1 hour
Rate of patients for each class of occlusion
The classes of occlusion are defined as : complete occlusion, residual neck, residual aneurysm, for the group treated with coiling procedure; grades 0 to 4 according to the scale of Kamran, for the group treated with flow diversion
Measured: Endovascular procedure , an expected average of 1 hour and 12 months
Modified Rankin score
Measured: Inclusion, 3 months and 12 months
National Institute of Health Stroke Score (NIHSS)
Measured: Inclusion, 3 months and 12 months
Evolution of the Barthel index
Measured: : Inclusion and 12 months
Incremental cost-effectiveness ratio
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 posted14 Mar 2013 (estimated)
- Study startNov 2012
- Primary completionNov 2015
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Hospices Civils de LyonThe 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
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francis TURJMAN, PH, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01811134
- Sponsor's protocol ID
- 2011.689
- Other IDs
- 2011-A01079-32
- Acronym
- EVIDENCE
- Status last verified
- Dec 2025
- First submitted
- 20 Nov 2012
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Turjman F, Levrier O, Combaz X, Bonafe A, Biondi A, Desal H, Bracard S, Mounayer C, Riva R, Chapuis F, Huot L, Armoiry X, Gory B. EVIDENCE trial: design of a phase 2, randomized, controlled, multicenter study comparing flow diversion and traditional endovascular strategy in unruptured saccular wide-necked intracranial aneurysms. Neuroradiology. 2015 Jan;57(1):49-54. doi: 10.1007/s00234-014-1439-7. Epub 2014 Oct 4.
PubMed 25280445
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Study for Medico-economic Evaluation of Embolization With Flow Diverter Stent in the Endovascular Treatment of Unruptured Saccular Wide-necked Intracranial Aneurysms
- ClinicalTrials.gov ID
- NCT01811134
- Acronym / sponsor ID
- EVIDENCE / 2011.689
- Conditions
- Intracranial Aneurysm
- Keywords
- endovascular procedure; flow diverter stent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Nov 2015 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 14 Mar 2013 (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.
Unruptured saccular intracranial aneurysms larger than 7 mm can be treated with endovascular occlusion using detachable coils, with or without expendable stent assistance. A new endovascular technique has recently been developed, using flow diverter stents without associated coils. Clinical results already published are encouraging but have to be confirmed. Furthermore, these medical devices are expensive in comparison to the coiling strategy. The purpose of this study is to compare the clinical efficacy, safety, and cost-effectiveness of endovascular coiling and endovascular flow diversion for unrupted saccular intracranial aneurysms.
Detailed description
Main Outcome Measure: Percentage of patients with an aneurysm with complete occlusion, defined as the absence of visible blood flow to the consideration of angiography performed 12 months post-endovascular intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PIPELINE flow diverter stent | Experimental | Device: PIPELINE flow diverter stent, Device: Coils, with or without expendable stentflow diverter stent |
| Coils, with or without expendable stent | Active comparator | Device: PIPELINE flow diverter stent, Device: Coils, with or without expendable stentCoils |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient's age ≥ 18 years old
- Unruptured saccular intracranial aneurysm diagnosed by angiography or CT angiography or MR angiography, located in the intra-dural area, with a neck diameter between 4 and 10 mm, with a sac diameter between 7 mm and 20 mm, with a ratio "dome/nek" greater than 1, and with a diameter of the parent artery between 2 and 5 mm.
- No prior treatment of the aneurysm
- Agreement for participating in the study and informed consent signed by the patient
- Patient affiliated to a social security scheme
Key exclusion criteria (11 listed)
- Patient's age < 18 years old
- Adult patient protected by law
- Contraindications to the endovascular procedure
- Contraindications to antiplatelet or anticoagulant treatment
- Prior treatment of the aneurysm
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 |
|---|---|---|
| PIPELINE flow diverter stentendovascular procedure using the medical device PIPELINE | Device | Coils, with or without expendable stent, PIPELINE flow diverter stent |
| Coils, with or without expendable stentendovascular embolization procedure using microspires, with the possibility of using a balloon temporary and / or implantation of a stent complementary intracranial before implementation of microspires | Device | Coils, with or without expendable stent, PIPELINE flow diverter stent |
Primary outcome
Percentage of patients with complete occlusion of the treated aneurysm, defined as the absence of visible blood flow on angiography performed 12 months after endovascular procedure.
Time frame: 12 months
17 secondary outcomes
Occurrence of a death during or after endovascular procedure
Time frame: hospitalization for the endovascular procedure, up to 7 days
Occurrence of a death whatever the cause
Time frame: 24 months
Occurrence of a death due to aneurysm rupture
Time frame: 24 months
Occurrence of an intracranial hemorrhagic from rupture of the aneurysm
Time frame: 24 months
Occurrence of an ischemic stroke due to thrombosis
Time frame: 24 months
Occurrence of a non-cerebral bleeding
Time frame: 24 months
Rate of patients with neurological deficits by mass effect
Time frame: hospitalization for the endovascular procedure, an expected average of 1 hour; 3 months, 6 months and 12 months post-intervention
Retreatment of the aneurysm
Time frame: 24 months
Rate of technical complications
Time frame: Endovascular procedure an expected average of 1 hour
Rate of thromboembolic complications, intraoperative ruptures, complications at the puncture site, or others
Time frame: Endovascular procedure an expected average of 1 hour
Rate of correct placement of flow diverter stents, according to the investigator
Time frame: Endovascular procedure an expected average of 1 hour
mean duration of irradiation related to angiography
Time frame: Endovascular procedure an expected average of 1 hour
Rate of patients for each class of occlusion
Time frame: Endovascular procedure , an expected average of 1 hour and 12 months
Modified Rankin score
Time frame: Inclusion, 3 months and 12 months
National Institute of Health Stroke Score (NIHSS)
Time frame: Inclusion, 3 months and 12 months
Evolution of the Barthel index
Time frame: : Inclusion and 12 months
Incremental cost-effectiveness ratio
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 19 Dec 2025.
- Results publication: PubMed 25280445Turjman F, Levrier O, Combaz X, Bonafe A, Biondi A, Desal H, Bracard S, Mounayer C, Riva R, Chapuis F, Huot L, Armoiry X, Gory B. EVIDENCE trial: design of a phase 2, randomized, controlled, multicenter study comparing flow diversion and traditional endovascular strategy in unruptured saccular wide-necked intracranial aneurysms. Neuroradiology. 2015 Jan;57(1):49-54. doi: 10.1007/s00234-014-1439-7. Epub 2014 Oct 4.
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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.
Francis TURJMAN, PH principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PIPELINE flow diverter stent and Coils, with or without expendable stent in people with Intracranial Aneurysm, run by Hospices Civils de Lyon at 1 site in France.
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 5 inclusion and 11 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 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
Percentage of patients with complete occlusion of the treated aneurysm, defined as the absence of visible blood flow on angiography performed 12 months after endovascular procedure. (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 NCT01811134, which also lists 1 linked publication.
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 19 Dec 2025.