Safety and Performance of the Penumbra Liberty Stent in the Treatment of Wide-Neck, Saccular, Intracranial Aneurysms

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and performance of the Penumbra Liberty Stent System as adjunctive treatment to embolic coils for wide-neck, saccular, intracranial aneurysms.

Official Title
-----------------
Safety and Performance of the Penumbra Liberty Stent in the Treatment of Wide-Neck, Saccular, Intracranial Aneurysms

Conditions
-----------------
Wide Neck Intracranial Aneurysms

Intervention / Treatment
-----------------
* Device: Liberty Stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient from 18 to 85 years old A symptomatic unruptured saccular intracranial aneurysm with a neck ≥4mm (or a dome to neck ratio <2) and a parent vessel diameter between 2.5 to 5.0 mm (inclusive) in both the anterior and posterior circulation of the brain, that is amenable to stent-assisted coiling. Symptomatic is defined as any neurological symptoms attributed to the target aneurysm. Life expectancy >6 months Signed Informed Consent Exclusion Criteria: Aneurysm with branches from the aneurysm base Rapidly growing aneurysm Daughter aneurysm Aneurysm with partial or complex calcifications Females who are nursing, pregnant or intend to become pregnant during the study. Females of child-bearing potential must have a urinary pregnancy test within 7 days of enrollment and use an approved highly efficient contraceptive method during the study Multiple untreated cerebral aneurysms at study entry Recent history of stroke, TIA, subarachnoid hemorrhage, intracranial hemorrhage, or major surgery within one month of enrollment Previous brain surgery or irradiation of the target treatment territory that would, in the opinion of the investigator, interfere with the treatment of the target aneurysm Admission platelet <150,000 or any known hemorrhagic diathesis, coagulation deficiency, or on oral anticoagulant therapy Underlying unstable Coronary Artery Disease, cardiac insufficiency or Myocardial Infarction Contraindication to angiography such as elevated creatinine or known allergy to angiographic contrast Contraindication to CT and/or MRI scans Known allergy to the metal component of the Penumbra Liberty Stent System Evidence of active infection (WBC >10x109/L) Any medical conditions that will not allow the necessary follow-up for this study (e.g., pre-existing neurological or psychiatric diseases) Current substance-abuse/illicit drug use Angiographic evidence of an arterial stenosis proximal to the target lesion that could prevent device deployment Contraindications to study medications (heparin, aspirin, clopidogrel, and radiographic contrasts) Patients unable to sign Informed Consent due to the emergency conditions of the intervention

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment by the Liberty Stent<br> | Device: Liberty Stent<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aneurysmal occlusion of the treated target lesion on 6-month angiography as defined by the method of Roy et al. (Stroke 2001;32:1998-2004). |  | 6 months post-procedure | 
| Procedural device-related serious adverse events |  | During the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device patency and migration |  | At 6 months post-procedure | 
| Intracranial hemorrhage |  | At 6 months post-procedure | 
| Functional outcome as defined by the modified Rankin Scale (mRS) |  | At 6 months post-procedure | 
| All cause mortality |  | At 6 months post-procedure | 
| Retreatment |  | At 6 months |