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

Cordis Neurovascular Feasibility Study of the Enterprise Self-Expanding Stent System to Facilitate Endovascular Coil Embolization of Wide- Neck Saccular Intracranial Artery Aneurysms

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00288405

Enrollment

Registered

2006-02-08

Start date

2004-06-30

Completion date

2005-12-31

Last updated

2012-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aneurysms

Keywords

Intracranial, Wide-neck, Saccular, Aneurysms

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).

Interventions

DEVICECordis Self Expanding Stent

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Patients with intracranial, wide-neck, saccular aneurysms

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Successful stent placement with satisfactory coil mass position angiographically.	immediately after post procedure

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026