A Feasibility Study of the Cordis Neurovascular Self Expanding Stent System in Intracranial Arteries

Study Overview
=================
Brief Summary
-----------------
Feasibility study to assess safety of treating patients with self expanding stent in intracranial arteries.

Detailed Description
-----------------
Feasibility study to assess safety of treating patients with self expanding stent in intracranial arteries. Patients will be followed for 6 months with assessments related to technical feasibility and adverse events.

Official Title
-----------------
A Feasibility Study of the Cordis Neurovascular Self Expanding Stent System in Intracranial Arteries

Conditions
-----------------
Atherosclerosis, Aneurysm

Intervention / Treatment
-----------------
* Device: Cordis Neurovascular ENTERPRISE Self Expanding Stent System
* Device: Cordis Neurovascular ENTERPRISE Self Expanding Stent System


Participation Criteria
=================
Eligibility Criteria
-----------------
Contact site for specific information Inclusion Criteria: Subject meet specific criteria for treatment Subject must be willing to return to site for 30 day and 6 month follow up evaluations Exclusion Criteria: Stenting, angioplasty or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to expected enrollment date Previously implanted carotid stent associated with the symptomatic distribution within the past 12 weeks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: Atherosclerosis Arm<br>Implant of Cordis Neurovascular ENTERPRISE Self Expanding Stent System | Device: Cordis Neurovascular ENTERPRISE Self Expanding Stent System<br>* Implantation of the device ENTERPRISE used to treat symptomatic stenosis in intracranial arteries.<br>* Other names: ENTERPRISE;|
| Active Comparator: Group 2: Aneurysm Arm<br>Implant of Cordis Neurovascular ENTERPRISE Self Expanding Stent System | Device: Cordis Neurovascular ENTERPRISE Self Expanding Stent System<br>* Implantation of the device ENTERPRISE to treat wide-necked aneurysms<br>* Other names: ENTERPRISE;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Feasibility- Successful Stent/Coil Placement (Post Procedure) | Successful placement of the product assessed immediately post procedure | post procedure | 
| Technical Feasibility- Percent Occlusion (Post Procedure) | Occlusion evaluated immediately post procedure | post procedure | 
| Technical Feasibility- Percent Occlusion (6 Mo Post Procedure) | 6 Months post | 6 mo | 
| Technical Feasibility- Successful Stent/Coil Placement (6 Mo Post Procedure) | Successful stent/coil placement assessed at 6 mo post | 6 mo | 
| Technical Feasibility- Percent Stenosis (6 mo Post Procedure) | Percent Stenosis assessed 6 mo Post Procedure from pre-procedure | 6 mo | 
| Technical Feasibility- Percent Stenosis (Post Procedure) | Percent Stenosis assessed immediately post procedure from pre procedure | Post Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Secondary Outcome Measure in Group 1, Atherosclerosis and in Group 2, Aneurysm, is the Evaluation of Adverse Events. The Groups Were Analyzed Separately. | An adverse event was defined as any untoward medical occurrence in a subject. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atherosclerosis,Wide Neck Aneurysm