Phase 1
N=20
A Feasibility Study of the Cordis Neurovascular Self Expanding Stent System in Intracranial Arteries
Atherosclerosis · Aneurysm
Bottom Line
View on ClinicalTrials.gov: NCT00349908 ↗Enrolled (actual)
20
Serious AEs
30.0%
Results posted
Oct 2013
Primary outcome: Primary: Technical Feasibility- Successful Stent/Coil Placement (Post Procedure) — 100; 90 percentage of stable placement
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Cordis Neurovascular ENTERPRISE Self Expanding Stent System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Codman & Shurtleff
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Technical Feasibility- Successful Stent/Coil Placement (Post Procedure) |
100; 90 | — |
| PRIMARY Technical Feasibility- Percent Occlusion (Post Procedure) |
86.8 | — |
| PRIMARY Technical Feasibility- Percent Occlusion (6 Mo Post Procedure) |
88.8 | — |
| PRIMARY Technical Feasibility- Successful Stent/Coil Placement (6 Mo Post Procedure) |
100; 100 | — |
| PRIMARY Technical Feasibility- Percent Stenosis (6 mo Post Procedure) |
-47.3 | — |
| PRIMARY Technical Feasibility- Percent Stenosis (Post Procedure) |
-38.5 | — |
| SECONDARY The Secondary Outcome Measure in Group 1, Atherosclerosis and in Group 2, Aneurysm, is the Evaluation of Adverse Events. The Groups Were Analyzed Separately. |
25; 28 | — |
Summary
Feasibility study to assess safety of treating patients with self expanding stent in intracranial arteries.
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
Data sourced from ClinicalTrials.gov (NCT00349908). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.