Study of the Enterprise Self-Expanding Stent System With Endovascular Coil Embolization of Wide- Neck Saccular Intracranial Artery Aneurysms

This study has been completed.
Information provided by:
Codman & Shurtleff Identifier:
First received: October 5, 2005
Last updated: January 5, 2009
Last verified: January 2009

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
Intracranial, Wide-Neck, Saccular Aneurysms
Device: Cordis Neurovascular Self-Expanding Stent
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
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:

Estimated Enrollment: 30
Study Start Date: January 2004
Estimated Study Completion Date: December 2005

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • pts with intracranial, wide-neck, saccular aneurysms

Exclusion Criteria:

  • Subject with Hunt and Hess Grade IV or V subarachnoid hemorrhage.
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

No publications provided Identifier: NCT00233753     History of Changes
Other Study ID Numbers: USCNVP-01
Study First Received: October 5, 2005
Last Updated: January 5, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Codman & Shurtleff:

Additional relevant MeSH terms:
Cardiovascular Diseases
Vascular Diseases processed this record on October 09, 2015