A Feasibility Study of the Cordis Neurovascular Self Expanding Stent System in Intracranial Arteries
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Atherosclerosis
- Sponsor
- Codman & Shurtleff
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Technical Feasibility- Successful Stent/Coil Placement (Post Procedure)
- Status
- Completed
- Last Updated
- 11 years ago
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Technical Feasibility- Successful Stent/Coil Placement (Post Procedure)
Time Frame: post procedure
Successful placement of the product assessed immediately post procedure
Technical Feasibility- Percent Occlusion (Post Procedure)
Time Frame: post procedure
Occlusion evaluated immediately post procedure
Technical Feasibility- Percent Occlusion (6 Mo Post Procedure)
Time Frame: 6 mo
6 Months post
Technical Feasibility- Successful Stent/Coil Placement (6 Mo Post Procedure)
Time Frame: 6 mo
Successful stent/coil placement assessed at 6 mo post
Technical Feasibility- Percent Stenosis (6 mo Post Procedure)
Time Frame: 6 mo
Percent Stenosis assessed 6 mo Post Procedure from pre-procedure
Technical Feasibility- Percent Stenosis (Post Procedure)
Time Frame: Post Procedure
Percent Stenosis assessed immediately post procedure from pre procedure
Secondary Outcomes
- The Secondary Outcome Measure in Group 1, Atherosclerosis and in Group 2, Aneurysm, is the Evaluation of Adverse Events. The Groups Were Analyzed Separately.(6 months)