The ENTERPRISE Study - Study of the Enterprise Self-Expanding Stent System

Aneurysms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00288405
• Other study ID #: EN-03-01
• Status: Completed
• Phase: Phase 1
• First received: October 5, 2005
• Last updated: April 30, 2012
• Start date: June 2004
• Est. completion date: December 2005

Study information

• Verified date: April 2012
• Source: Codman & Shurtleff
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of HealthGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with intracranial, wide-neck, saccular aneurysms

Exclusion Criteria:

• Subject with Hunt and Hess Grade IV or V subarachnoid hemorrhage

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aneurysm
• Aneurysms

Intervention

Device:
• Cordis Self Expanding Stent

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Codman & Shurtleff

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

Weber W, Bendszus M, Kis B, Boulanger T, Solymosi L, Kühne 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful stent placement with satisfactory coil mass position angiographically.		immediately after post procedure