NCT00288405

Brief Summary

To evaluate the safety and feasibility of the Cordis Neurovascular Self-Expanding Stent System to facilitate endovascular coil embolization of wide neck saccular intracranial aneurysms. Cordis Self Expanding Stent for use with embolic coils for the treatment of wide-neck, intracranial, saccular aneurysms arising from a parent vessel

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2004

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

Study Start

First participant enrolled

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 8, 2006

Completed
Last Updated

May 2, 2012

Status Verified

April 1, 2012

First QC Date

October 5, 2005

Last Update Submit

April 30, 2012

Conditions

Aneurysms

Keywords

IntracranialWide-neckSaccularAneurysms

Outcome Measures

Primary Outcomes (1)

  • Successful stent placement with satisfactory coil mass position angiographically.

    immediately after post procedure

Interventions

Cordis Self Expanding StentDEVICE

Eligibility Criteria

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

You may qualify if:

  • Patients with intracranial, wide-neck, saccular aneurysms

You may not qualify if:

  • Subject with Hunt and Hess Grade IV or V subarachnoid hemorrhage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliera

Milan, 20162, Italy

Location

Related Publications (2)

  • Higashida RT, Halbach VV, Dowd CF, Juravsky L, Meagher S. Initial clinical experience with a new self-expanding nitinol stent for the treatment of intracranial cerebral aneurysms: the Cordis Enterprise stent. AJNR Am J Neuroradiol. 2005 Aug;26(7):1751-6.

    PMID: 16091525BACKGROUND

  • Weber W, Bendszus M, Kis B, Boulanger T, Solymosi L, Kuhne D. A new self-expanding nitinol stent (Enterprise) for the treatment of wide-necked intracranial aneurysms: initial clinical and angiographic results in 31 aneurysms. Neuroradiology. 2007 Jul;49(7):555-61. doi: 10.1007/s00234-007-0232-2. Epub 2007 May 3.

    PMID: 17476494RESULT

MeSH Terms

Conditions

Aneurysm

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Edoardo Boccardi, MD

    Azienda Ospedaliera

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 5, 2005

First Posted

February 8, 2006

Study Start

June 1, 2004

Study Completion

December 1, 2005

Last Updated

May 2, 2012

Record last verified: 2012-04

Locations

IT(1)