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Completed

NCT Number: NCT00288405

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

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

Completed

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Key information

Conditions

Aneurysms Aneurysm Cardiovascular Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Azienda Ospedaliera

Milan, 20162, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with intracranial, wide-neck, saccular aneurysms

Exclusion criteria

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

Treatment and study plan

Cordis Self Expanding Stent

Device

Primary outcomes

  1. Successful stent placement with satisfactory coil mass position angiographically.

    Time frame: immediately after post procedure

Sponsors and collaborators

Lead sponsor

Codman & Shurtleff

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2005
First posted
Feb 8, 2006
Registry last updated
May 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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