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

This study has been completed.
Sponsor:
Information provided by:
Codman & Shurtleff
ClinicalTrials.gov Identifier:
NCT00233753
First received: October 5, 2005
Last updated: January 5, 2009
Last verified: January 2009
  Purpose

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
  Eligibility

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

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
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.

No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov 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:
Intracranial
Wide-neck
Saccular
Aneurysms

Additional relevant MeSH terms:
Aneurysm
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 14, 2014