Flow Diverter Stent for Endovascular Treatment of Unruptured Saccular Wide-necked Intracranial Aneurysms
- Conditions
- Intracranial Aneurysm
- Interventions
- Device: PIPELINE flow diverter stentDevice: Coils, with or without expendable stent
- Registration Number
- NCT01811134
- Lead Sponsor
- Hospices Civils de Lyon
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 91
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PIPELINE flow diverter stent PIPELINE flow diverter stent flow diverter stent PIPELINE flow diverter stent Coils, with or without expendable stent flow diverter stent Coils, with or without expendable stent PIPELINE flow diverter stent Coils Coils, with or without expendable stent Coils, with or without expendable stent Coils
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Incremental cost-effectiveness ratio 12 months Occurrence of a death during or after endovascular procedure hospitalization for the endovascular procedure, up to 7 days 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 Retreatment of the aneurysm 24 months Rate of technical complications Endovascular procedure an expected average of 1 hour Rate of thromboembolic complications, intraoperative ruptures, complications at the puncture site, or others Endovascular procedure an expected average of 1 hour 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 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
Trial Locations
- Locations (1)
Hospices Civils de Lyon
🇫🇷Lyon, Bron, France