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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
  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:


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
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, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014