Back to resultsThe ENTERPRISE Study - Study of the Enterprise Self-Expanding Stent System
Primary Purpose
Aneurysms
Status
Completed
Phase
Phase 1
Locations
Italy
Study Type
Interventional
Intervention
Cordis Self Expanding Stent
Sponsored by
About this trial
This is an interventional treatment trial for Aneurysms focused on measuring Intracranial, Wide-neck, Saccular, Aneurysms
Eligibility Criteria
Inclusion Criteria: Patients with intracranial, wide-neck, saccular aneurysms Exclusion Criteria: Subject with Hunt and Hess Grade IV or V subarachnoid hemorrhage
Sites / Locations
- Azienda Ospedaliera
Outcomes
Primary Outcome Measures
Successful stent placement with satisfactory coil mass position angiographically.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00288405
Brief Title
The ENTERPRISE Study - Study of the Enterprise Self-Expanding Stent System
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Codman & Shurtleff
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aneurysms
Keywords
Intracranial, Wide-neck, Saccular, Aneurysms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Cordis Self Expanding Stent
Primary Outcome Measure Information:
Title
Successful stent placement with satisfactory coil mass position angiographically.
Time Frame
immediately after post procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with intracranial, wide-neck, saccular aneurysms
Exclusion Criteria:
Subject with Hunt and Hess Grade IV or V subarachnoid hemorrhage
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edoardo Boccardi, MD
Organizational Affiliation
Azienda Ospedaliera
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Ospedaliera
City
Milano
ZIP/Postal Code
20162
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
16091525
Citation
Higashida RT, Halbach VV, Dowd CF, Juravsky L, Meagher S. Initial clinical experience with a new self-expanding nitinol stent for the treatment of intracranial cerebral aneurysms: the Cordis Enterprise stent. AJNR Am J Neuroradiol. 2005 Aug;26(7):1751-6.
Results Reference
background
PubMed Identifier
17476494
Citation
Weber W, Bendszus M, Kis B, Boulanger T, Solymosi L, Kuhne D. A new self-expanding nitinol stent (Enterprise) for the treatment of wide-necked intracranial aneurysms: initial clinical and angiographic results in 31 aneurysms. Neuroradiology. 2007 Jul;49(7):555-61. doi: 10.1007/s00234-007-0232-2. Epub 2007 May 3.
Results Reference
result
Learn more about this trial
The ENTERPRISE Study - Study of the Enterprise Self-Expanding Stent System
We'll reach out to this number within 24 hrs