We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The ENTERPRISE Study - Study of the Enterprise Self-Expanding Stent System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00288405
Recruitment Status : Completed
First Posted : February 8, 2006
Last Update Posted : May 2, 2012
Sponsor:
Information provided by:

Study Description
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


Condition or disease Intervention/treatment Phase
Aneurysms Device: Cordis Self Expanding Stent Phase 1

Detailed Description:
This is a multi-center, prospective, non-randomized feasibility study including 30 subjects. Subjects will receive a safety follow-up evaluation at 30 days (+ two weeks) and an efficacy follow-up evaluation at 6 months (+ four weeks).

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cordis Neurovascular Feasibility Study of the Enterprise Self-Expanding Stent System to Facilitate Endovascular Coil Embolization of Wide- Neck Saccular Intracranial Artery Aneurysms
Study Start Date : June 2004
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Successful stent placement with satisfactory coil mass position angiographically. [ Time Frame: immediately after post procedure ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with intracranial, wide-neck, saccular aneurysms

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00288405


Locations
Italy
Azienda Ospedaliera
Milano, Italy, 20162
Sponsors and Collaborators
Codman & Shurtleff
Investigators
Principal Investigator: Edoardo Boccardi, MD Azienda Ospedaliera