Clinical trial NCT01811134: Flow Diverter Stent for Endovascular Treatment of Unruptured Saccular Wide-necked Intracranial Aneurysms
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracranial Aneurysm
Keywords: endovascular procedure; flow diverter stent
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2013-03-14
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Extradural location of the aneurysm
* Fusiform aneurysm
* Active bacterial infection (clinical signs)
* Intracranial hemorrhage from aneurysm in the previous month
* Pregnant or breastfeeding woman

Primary outcomes:
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.
timeFrame: 12 months
Secondary outcomes:
measure: Occurrence of a death during or after endovascular procedure
timeFrame: hospitalization for the endovascular procedure, up to 7 days
measure: Occurrence of a death whatever the cause
timeFrame: 24 months
measure: Occurrence of a death due to aneurysm rupture
timeFrame: 24 months
measure: Occurrence of an intracranial hemorrhagic from rupture of the aneurysm
timeFrame: 24 months
measure: Occurrence of an ischemic stroke due to thrombosis
timeFrame: 24 months
measure: Occurrence of a non-cerebral bleeding
timeFrame: 24 months
measure: Rate of patients with neurological deficits by mass effect
timeFrame: hospitalization for the endovascular procedure, an expected average of 1 hour; 3 months, 6 months and 12 months post-intervention
measure: Retreatment of the aneurysm
timeFrame: 24 months
measure: Rate of technical complications
timeFrame: Endovascular procedure an expected average of 1 hour
measure: Rate of thromboembolic complications, intraoperative ruptures, complications at the puncture site, or others
timeFrame: Endovascular procedure an expected average of 1 hour
measure: Rate of correct placement of flow diverter stents, according to the investigator
timeFrame: Endovascular procedure an expected average of 1 hour
measure: mean duration of irradiation related to angiography
timeFrame: Endovascular procedure an expected average of 1 hour
measure: Rate of patients for each class of occlusion
timeFrame: Endovascular procedure , an expected average of 1 hour and 12 months
measure: Modified Rankin score
timeFrame: Inclusion, 3 months and 12 months
measure: National Institute of Health Stroke Score (NIHSS)
timeFrame: Inclusion, 3 months and 12 months
measure: Evolution of the Barthel index
timeFrame: : Inclusion and 12 months
measure: Incremental cost-effectiveness ratio
timeFrame: 12 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
state: Bron
Study officials:
affiliation: Hospices Civils de Lyon
name: Francis TURJMAN, PH
role: PRINCIPAL_INVESTIGATOR
References: