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

This study is ongoing, but not recruiting participants.

First Received: July 6, 2006 Last Updated: January 5, 2009 History of Changes

Sponsored by:	Codman & Shurtleff
Information provided by:	Codman & Shurtleff
ClinicalTrials.gov Identifier:	NCT00349908

Purpose

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

Condition	Intervention	Phase
Atherosclerosis Aneurysm	Device: Cordis Neurovascular Self Expanding Stent System	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Feasibility Study of the Cordis Neurovascular Self Expanding Stent System in Intracranial Arteries

Resource links provided by NLM:

MedlinePlus related topics: Aneurysms

U.S. FDA Resources

Further study details as provided by Codman & Shurtleff:

Primary Outcome Measures:

Adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Neurological Status [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment:	21
Study Start Date:	September 2006
Estimated Study Completion Date:	January 2009
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Implantation of Cordis Neurovascular Self Expanding Stent System

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 adverse events and neurological function.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00349908

Locations

Argentina
Eneri-clinica Adventista Belgrano
Belgrano, Argentina

Sponsors and Collaborators

Codman & Shurtleff

Investigators

Principal Investigator:

Pedro Lylyk, MD

ENERI-CLINICA ADVENTISTA BELGRANO

More Information

No publications provided

Responsible Party:	Cordis ( H. Wayne Hutman, MD / Director )
Study ID Numbers:	CNV:ARG:P-01
Study First Received:	July 6, 2006
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00349908 History of Changes
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Codman & Shurtleff:

Atherosclerosis,Wide Neck Aneurysm

Study placed in the following topic categories:

Arterial Occlusive Diseases
Atherosclerosis
Aneurysm
Vascular Diseases
Arteriosclerosis

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Atherosclerosis
Aneurysm

Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis

ClinicalTrials.gov processed this record on September 11, 2009