Other Clinical Trial - Study of the Enterprise NCT00233753

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Details — Status: Completed

Study information
Verified date	January 2009
Source	Codman & Shurtleff
Contact	n/a
Is FDA regulated	No
Health authority	United States: Food and Drug Administration
Study type	Interventional

Cordis Self Expanding Stent for use with embolic coils for the treatment of wide-neck, intracranial, saccular aneurysms arising from a parent vessel

Recruitment information / eligibility
Status	Completed
Enrollment	30
Est. completion date	December 2005
Est. primary completion date
Accepts healthy volunteers	No
Gender	Both
Age group	18 Years to 80 Years
Eligibility	Inclusion Criteria: - pts with intracranial, wide-neck, saccular aneurysms Exclusion Criteria: - Subject with Hunt and Hess Grade IV or V subarachnoid hemorrhage.

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Primary Purpose: Treatment

Device:
• Cordis Neurovascular Self-Expanding Stent

Locations
Country	Name	City	State
n/a

Sponsors *(1)*
Lead Sponsor	Collaborator
Codman & Shurtleff