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

May 28, 2014 updated by: Codman & Shurtleff
Feasibility study to assess safety of treating patients with self expanding stent in intracranial arteries.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Belgrano, Argentina
        • Eneri-Clinica Adventista Belgrano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1: Atherosclerosis Arm
Implant of Cordis Neurovascular ENTERPRISE Self Expanding Stent System
Device: Cordis Neurovascular ENTERPRISE Self Expanding Stent System
Implantation of the device ENTERPRISE used to treat symptomatic stenosis in intracranial arteries.
Other Names:
  • Other Names:
  • ENTERPRISE Vascular Reconstruction Device (VRD)
  • ENTERPRISE VRD
  • ENTERPRISE
Device: Cordis Neurovascular ENTERPRISE Self Expanding Stent System
Implantation of the device ENTERPRISE to treat wide-necked aneurysms
Other Names:
  • ENTERPRISE Vascular Reconstruction Device (VRD)
  • ENTERPRISE VRD
  • ENTERPRISE
Active Comparator: Group 2: Aneurysm Arm
Implant of Cordis Neurovascular ENTERPRISE Self Expanding Stent System
Device: Cordis Neurovascular ENTERPRISE Self Expanding Stent System
Implantation of the device ENTERPRISE used to treat symptomatic stenosis in intracranial arteries.
Other Names:
  • Other Names:
  • ENTERPRISE Vascular Reconstruction Device (VRD)
  • ENTERPRISE VRD
  • ENTERPRISE
Device: Cordis Neurovascular ENTERPRISE Self Expanding Stent System
Implantation of the device ENTERPRISE to treat wide-necked aneurysms
Other Names:
  • ENTERPRISE Vascular Reconstruction Device (VRD)
  • ENTERPRISE VRD
  • ENTERPRISE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Secondary Outcome Measure in Group 1, Atherosclerosis and in Group 2, Aneurysm, is the Evaluation of Adverse Events. The Groups Were Analyzed Separately.
Time Frame: 6 months
An adverse event was defined as any untoward medical occurrence in a subject.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Codman & Shurtleff

Investigators

  • Principal Investigator: Pedro Lylyk, MD, Eneri-Clinica Adventista Belgrano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

July 6, 2006

First Submitted That Met QC Criteria

July 6, 2006

First Posted (Estimate)

July 10, 2006

Study Record Updates

Last Update Posted (Estimate)

June 30, 2014

Last Update Submitted That Met QC Criteria

May 28, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNV:ARG:P-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atherosclerosis

Clinical Trials on Cordis Neurovascular ENTERPRISE Self Expanding Stent System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe