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

Codman & Shurtleff20 enrolled

Overview

Feasibility study to assess safety of treating patients with self expanding stent in intracranial arteries.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Atherosclerosis Aneurysm

Interventions

Cordis Neurovascular ENTERPRISE Self Expanding Stent SystemDEVICE

Implantation of the device ENTERPRISE used to treat symptomatic stenosis in intracranial arteries.

Cordis Neurovascular ENTERPRISE Self Expanding Stent SystemDEVICE

Implantation of the device ENTERPRISE to treat wide-necked aneurysms

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Eneri-Clinica Adventista Belgrano

Belgrano, Argentina

Outcomes

Primary Outcomes

Technical Feasibility- Successful Stent/Coil Placement (Post Procedure)

Successful placement of the product assessed immediately post procedure

Time frame: post procedure

Technical Feasibility- Percent Occlusion (Post Procedure)

Occlusion evaluated immediately post procedure

Time frame: post procedure

Technical Feasibility- Percent Occlusion (6 Mo Post Procedure)

6 Months post

Time frame: 6 mo

Technical Feasibility- Successful Stent/Coil Placement (6 Mo Post Procedure)

Successful stent/coil placement assessed at 6 mo post

Time frame: 6 mo

Technical Feasibility- Percent Stenosis (6 mo Post Procedure)

Percent Stenosis assessed 6 mo Post Procedure from pre-procedure

Time frame: 6 mo

Technical Feasibility- Percent Stenosis (Post Procedure)

Percent Stenosis assessed immediately post procedure from pre procedure

Time frame: Post 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.

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

Time frame: 6 months

Data from ClinicalTrials.gov

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