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

NCT ID: NCT00288405

Last Updated: 2012-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2005-12-31

Brief Summary

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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

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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).

Conditions

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Aneurysms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Cordis Self Expanding Stent

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with intracranial, wide-neck, saccular aneurysms

Exclusion Criteria

* Subject with Hunt and Hess Grade IV or V subarachnoid hemorrhage
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Codman & Shurtleff

INDUSTRY

Sponsor Role lead

Principal Investigators

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Edoardo Boccardi, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliera

Locations

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Azienda Ospedaliera

Milan, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 16091525 (View on PubMed)

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.

Reference Type RESULT
PMID: 17476494 (View on PubMed)

Other Identifiers

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EN-03-01

Identifier Type: -

Identifier Source: org_study_id

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