Back to resultsA Feasibility Study of the Cordis Neurovascular Self Expanding Stent System in Intracranial Arteries
Primary Purpose
Atherosclerosis, Aneurysm
Status
Completed
Phase
Phase 1
Locations
Argentina
Study Type
Interventional
Intervention
Cordis Neurovascular ENTERPRISE Self Expanding Stent System
Cordis Neurovascular ENTERPRISE Self Expanding Stent System
Sponsored by
About this trial
This is an interventional treatment trial for Atherosclerosis focused on measuring Atherosclerosis,Wide Neck Aneurysm
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
Sites / Locations
- Eneri-Clinica Adventista Belgrano
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group 1: Atherosclerosis Arm
Group 2: Aneurysm Arm
Arm Description
Implant of Cordis Neurovascular ENTERPRISE Self Expanding Stent System
Implant of Cordis Neurovascular ENTERPRISE Self Expanding Stent System
Outcomes
Primary Outcome Measures
Technical Feasibility- Successful Stent/Coil Placement (Post Procedure)
Successful placement of the product assessed immediately post procedure
Technical Feasibility- Percent Occlusion (Post Procedure)
Occlusion evaluated immediately post procedure
Technical Feasibility- Percent Occlusion (6 Mo Post Procedure)
6 Months post
Technical Feasibility- Successful Stent/Coil Placement (6 Mo Post Procedure)
Successful stent/coil placement assessed at 6 mo post
Technical Feasibility- Percent Stenosis (6 mo Post Procedure)
Percent Stenosis assessed 6 mo Post Procedure from pre-procedure
Technical Feasibility- Percent Stenosis (Post Procedure)
Percent Stenosis assessed immediately post procedure from pre procedure
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00349908
Brief Title
A Feasibility Study of the Cordis Neurovascular Self Expanding Stent System in Intracranial Arteries
Official Title
A Feasibility Study of the Cordis Neurovascular Self Expanding Stent System in Intracranial Arteries
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Codman & Shurtleff
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis, Aneurysm
Keywords
Atherosclerosis,Wide Neck Aneurysm
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1: Atherosclerosis Arm
Arm Type
Experimental
Arm Description
Implant of Cordis Neurovascular ENTERPRISE Self Expanding Stent System
Arm Title
Group 2: Aneurysm Arm
Arm Type
Active Comparator
Arm Description
Implant of Cordis Neurovascular ENTERPRISE Self Expanding Stent System
Intervention Type
Device
Intervention Name(s)
Cordis Neurovascular ENTERPRISE Self Expanding Stent System
Other Intervention Name(s)
Other Names:, ENTERPRISE Vascular Reconstruction Device (VRD), ENTERPRISE VRD, ENTERPRISE
Intervention Description
Implantation of the device ENTERPRISE used to treat symptomatic stenosis in intracranial arteries.
Intervention Type
Device
Intervention Name(s)
Cordis Neurovascular ENTERPRISE Self Expanding Stent System
Other Intervention Name(s)
ENTERPRISE Vascular Reconstruction Device (VRD), ENTERPRISE VRD, ENTERPRISE
Intervention Description
Implantation of the device ENTERPRISE to treat wide-necked aneurysms
Primary Outcome Measure Information:
Title
Technical Feasibility- Successful Stent/Coil Placement (Post Procedure)
Description
Successful placement of the product assessed immediately post procedure
Time Frame
post procedure
Title
Technical Feasibility- Percent Occlusion (Post Procedure)
Description
Occlusion evaluated immediately post procedure
Time Frame
post procedure
Title
Technical Feasibility- Percent Occlusion (6 Mo Post Procedure)
Description
6 Months post
Time Frame
6 mo
Title
Technical Feasibility- Successful Stent/Coil Placement (6 Mo Post Procedure)
Description
Successful stent/coil placement assessed at 6 mo post
Time Frame
6 mo
Title
Technical Feasibility- Percent Stenosis (6 mo Post Procedure)
Description
Percent Stenosis assessed 6 mo Post Procedure from pre-procedure
Time Frame
6 mo
Title
Technical Feasibility- Percent Stenosis (Post Procedure)
Description
Percent Stenosis assessed immediately post procedure from pre procedure
Time Frame
Post Procedure
Secondary Outcome Measure Information:
Title
The Secondary Outcome Measure in Group 1, Atherosclerosis and in Group 2, Aneurysm, is the Evaluation of Adverse Events. The Groups Were Analyzed Separately.
Description
An adverse event was defined as any untoward medical occurrence in a subject.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro Lylyk, MD
Organizational Affiliation
ENERI-CLINICA ADVENTISTA BELGRANO
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eneri-Clinica Adventista Belgrano
City
Belgrano
Country
Argentina
12. IPD Sharing Statement
Learn more about this trial
A Feasibility Study of the Cordis Neurovascular Self Expanding Stent System in Intracranial Arteries
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