Intracranial Aneurysm
Conditions
Keywords
endovascular procedure; flow diverter stent
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.
Interventions
DEVICEPIPELINE flow diverter stent
endovascular procedure using the medical device PIPELINE
DEVICECoils, with or without expendable stent
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
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of a death whatever the cause | 24 months | — |
| Occurrence of a death due to aneurysm rupture | 24 months | — |
| Occurrence of an intracranial hemorrhagic from rupture of the aneurysm | 24 months | — |
| Occurrence of an ischemic stroke due to thrombosis | 24 months | — |
| Occurrence of a non-cerebral bleeding | 24 months | — |
| Rate of patients with neurological deficits by mass effect | hospitalization for the endovascular procedure, an expected average of 1 hour; 3 months, 6 months and 12 months post-intervention | — |
| Retreatment of the aneurysm | 24 months | — |
| Rate of technical complications | Endovascular procedure an expected average of 1 hour | — |
| Occurrence of a death during or after endovascular procedure | hospitalization for the endovascular procedure, up to 7 days | — |
| Rate of correct placement of flow diverter stents, according to the investigator | Endovascular procedure an expected average of 1 hour | — |
| mean duration of irradiation related to angiography | Endovascular procedure an expected average of 1 hour | — |
| Rate of patients for each class of occlusion | Endovascular procedure , an expected average of 1 hour and 12 months | 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 |
| Modified Rankin score | Inclusion, 3 months and 12 months | — |
| National Institute of Health Stroke Score (NIHSS) | Inclusion, 3 months and 12 months | — |
| Evolution of the Barthel index | : Inclusion and 12 months | — |
| Incremental cost-effectiveness ratio | 12 months | — |
| Rate of thromboembolic complications, intraoperative ruptures, complications at the puncture site, or others | Endovascular procedure an expected average of 1 hour | — |
Countries
France
Outcome results
None listed