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Enterprise 2 Vascular Reconstruction Device

NCT05254067 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2026-05-18

No results posted yet for this study

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 configuration.

Conditions

  • Aneurysm

Interventions

DEVICE

Codman Enterprise 2 Vascular Reconstruction Device

a self-expanding nitinol, compliant, closed-cell, recapturable design that can be deployed by a single operator designed to assist in the stent-assisted coil embolization of intracranial aneurysms, specifically those that have a wide neck that would not otherwise maintain the coil embolization material within the aneurysm because of the wide opening at the base of the aneurysm.

Sponsors & Collaborators

  • Methodist Health System

    lead OTHER

Principal Investigators

  • Bartley Mitchell, MD · Methodist Dallas Medical Center Neurovascular Surgery

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-28
Primary Completion
2026-01-05
Completion
2026-01-05
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05254067 on ClinicalTrials.gov