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

Phase 1

Completed

• Conditions: Atherosclerosis; Aneurysm
• Interventions: Device: Cordis Neurovascular ENTERPRISE Self Expanding Stent System

• Registration Number: NCT00349908
• Lead Sponsor: Codman & Shurtleff

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.

Study Timeline

• Study First Submitted: 2006-07-06
• Study First Submitted QC: 2006-07-06
• Study First Posted: 2006-07-10
• Study Start: 2006-09
• Primary Completion: 2008-10
• Study Completion: 2009-03
• Results First Submitted: 2011-02-02
• Results First Submitted QC: 2013-08-05
• Results First Posted: 2013-10-11
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-28
• Last Update Posted: 2014-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: Atherosclerosis Arm	Cordis Neurovascular ENTERPRISE Self Expanding Stent System	Implant of Cordis Neurovascular ENTERPRISE Self Expanding Stent System
Group 2: Aneurysm Arm	Cordis Neurovascular ENTERPRISE Self Expanding Stent System	Implant of Cordis Neurovascular ENTERPRISE Self Expanding Stent System

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	An adverse event was defined as any untoward medical occurrence in a subject.

Trial Locations

Locations (1)

Eneri-Clinica Adventista Belgrano; 🇦🇷 Belgrano, Argentina