NCT00349908

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2006

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

October 11, 2013

Completed
Last Updated

June 30, 2014

Status Verified

May 1, 2014

Enrollment Period

2.1 years

First QC Date

July 6, 2006

Results QC Date

February 2, 2011

Last Update Submit

May 28, 2014

Conditions

AtherosclerosisAneurysm

Keywords

Atherosclerosis,Wide Neck Aneurysm

Outcome Measures

Primary Outcomes (6)

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

    Successful placement of the product assessed immediately post procedure

    post procedure

  • Technical Feasibility- Percent Occlusion (Post Procedure)

    Occlusion evaluated immediately post procedure

    post procedure

  • Technical Feasibility- Percent Occlusion (6 Mo Post Procedure)

    6 Months post

    6 mo

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

    Successful stent/coil placement assessed at 6 mo post

    6 mo

  • Technical Feasibility- Percent Stenosis (6 mo Post Procedure)

    Percent Stenosis assessed 6 mo Post Procedure from pre-procedure

    6 mo

  • Technical Feasibility- Percent Stenosis (Post Procedure)

    Percent Stenosis assessed immediately post procedure from pre procedure

    Post Procedure

Secondary Outcomes (1)

  • 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

Study Arms (2)

Group 1: Atherosclerosis Arm

EXPERIMENTAL

Implant of Cordis Neurovascular ENTERPRISE Self Expanding Stent System

Device: Cordis Neurovascular ENTERPRISE Self Expanding Stent System

Group 2: Aneurysm Arm

ACTIVE COMPARATOR

Implant of Cordis Neurovascular ENTERPRISE Self Expanding Stent System

Device: Cordis Neurovascular ENTERPRISE Self Expanding Stent System

Interventions

Cordis Neurovascular ENTERPRISE Self Expanding Stent SystemDEVICE

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

Also known as: Other Names:, ENTERPRISE Vascular Reconstruction Device (VRD), ENTERPRISE VRD, ENTERPRISE
Group 1: Atherosclerosis Arm

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject meet specific criteria for treatment
  • Subject must be willing to return to site for 30 day and 6 month follow up evaluations

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eneri-Clinica Adventista Belgrano

Belgrano, Argentina

Location

MeSH Terms

Conditions

AtherosclerosisAneurysm

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
J. Thomas Megerian, MD
Organization
Codman & Shurtleff
jmegerian1@its.jnj.com
508.828.8274

Study Officials

  • Pedro Lylyk, MD

    ENERI-CLINICA ADVENTISTA BELGRANO

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2006

First Posted

July 10, 2006

Study Start

September 1, 2006

Primary Completion

October 1, 2008

Study Completion

March 1, 2009

Last Updated

June 30, 2014

Results First Posted

October 11, 2013

Record last verified: 2014-05

Locations

AR(1)