Status:

ENROLLING_BY_INVITATION

Enterprise 2 Vascular Reconstruction Device

Lead Sponsor:

Methodist Health System

Conditions:

Aneurysm

Eligibility:

All Genders

18+ years

Brief Summary

The primary objective of this study is to collect data regarding the effectiveness of using the Enterprise 2 Reconstruction Device in successfully embolizing intracranial aneurysms with wide neck conf...

Detailed Description

The Codman Enterprise 2 Vascular Reconstruction Device is a self-expanding nitinol, compliant, closed-cell, recapturable design that can be deployed by a single operator. The Codman Enterprise 2 Vascu...

Eligibility Criteria

Inclusion

  • Adult patients (18 years old or older) with intracranial aneurysms with a wide neck (defined as \> or = to 4mm, or with a dome to neck ratio of 2:1 or greater).

Exclusion

  • Small-necked aneurysms, inappropriate for stenting.
  • Inability to tolerate anti-platelet medication.

Key Trial Info

Start Date :

February 28 2017

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

February 1 2025

Estimated Enrollment :

10 Patients enrolled

Trial Details

Trial ID

NCT05254067

Start Date

February 28 2017

End Date

February 1 2025

Last Update

November 20 2024

Active Locations (1)

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1

Moody Brain and Spine Institute at Methodist Dallas Medical Center

Dallas, Texas, United States, 75203