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Search / Trial NCT05254067

Enterprise 2 Vascular Reconstruction Device

Launched by METHODIST HEALTH SYSTEM · Feb 21, 2022

Trial Information

Current as of June 26, 2025

Enrolling by invitation

Keywords

ClinConnect Summary

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 Vascular Reconstruction Device is packaged sterile as a single unit with an introducer sheath and a detachable push wire.

This device was 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 aneu...

Gender

ALL

Eligibility criteria

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

About Methodist Health System

Methodist Health System is a leading healthcare provider dedicated to advancing medical research and improving patient outcomes through innovative clinical trials. With a commitment to excellence in patient care and scientific inquiry, the organization leverages its state-of-the-art facilities and multidisciplinary expertise to conduct rigorous studies across various therapeutic areas. Methodist Health System collaborates with healthcare professionals, researchers, and industry partners to enhance the understanding of diseases and develop new treatment modalities, ensuring that cutting-edge therapies are accessible to the communities it serves. Through its clinical trial initiatives, Methodist Health System aims to contribute to the evolving landscape of medicine while prioritizing patient safety and ethical standards.

Locations

Dallas, Texas, United States

Patients applied

0 patients applied

Trial Officials

Bartley Mitchell, MD

Principal Investigator

Methodist Dallas Medical Center Neurovascular Surgery

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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