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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
91
endovascular procedure using the medical device PIPELINE
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
Hospices Civils de Lyon
Lyon, BRON, France
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
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
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
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
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