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

This study has been completed.
Sponsor:
Information provided by:
Codman & Shurtleff
ClinicalTrials.gov Identifier:
NCT00288405
First received: October 5, 2005
Last updated: April 30, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention Phase
Aneurysms
 Device: Cordis Self Expanding Stent
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Aneurysms
U.S. FDA Resources

Further study details as provided by Codman & Shurtleff:

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

Enrollment: 31
Study Start Date: June 2004
Study Completion Date: December 2005
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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00288405

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

Publications:

ClinicalTrials.gov Identifier: NCT00288405     History of Changes
Other Study ID Numbers: EN-03-01
Study First Received: October 5, 2005
Last Updated: April 30, 2012
Health Authority: Italy: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Codman & Shurtleff:
Intracranial
Wide-neck
Saccular
Aneurysms

Additional relevant MeSH terms:
Aneurysm
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 13, 2013