Flow Diverter Stent for Endovascular Treatment of Unruptured Saccular Wide-necked Intracranial Aneurysms

Study Overview
=================
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.

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

Conditions
-----------------
Intracranial Aneurysm

Intervention / Treatment
-----------------
* Device: PIPELINE flow diverter stent
* Device: Coils, with or without expendable stent


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PIPELINE flow diverter stent<br>flow diverter stent | Device: PIPELINE flow diverter stent<br>* endovascular procedure using the medical device PIPELINE<br>Device: Coils, with or without expendable stent<br>* 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<br>|
| Active Comparator: Coils, with or without expendable stent<br>Coils | Device: PIPELINE flow diverter stent<br>* endovascular procedure using the medical device PIPELINE<br>Device: Coils, with or without expendable stent<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 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 | Endovascular procedure , an expected average of 1 hour and 12 months | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endovascular procedure; flow diverter stent