Enterprise 2 Vascular Reconstruction Device

NCT05254067 | Enrolling By Invitation FDA Device

• 1 other identifier: 001.VAS.2017.D
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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 configuration.

Conditions

Aneurysm

Outcome Measures

Primary Outcomes (3)

• Device Effectiveness-Stent Migration

  Prior Observation studies have noted in other stents, that over time, a stent may migrate from its original location, given the flow dynamics and potentially from stent under-sizing. This could potentially disrupt flow through the artery, or even uncover the aneurysm, openining, potentially allowing outflow of embolization coils.

  Patients will be followed for a minimum period of 2 years from the date of the procedure, with planned total duration of 4 years of the study, including follow-up time.

• Device Effectiveness- Stent Fore-shortening

  If a stent contracts slightly after placement, then it could shorten slightly, particularly if the stent is placed around a tortous corner. In this type of event, generally there is no significant impact to the patient, unless the stent were to shorten and uncover the opening of the aneurysm, potentially allowing embolization coils to come out of the aneurysm.

  Patients will be followed for a minimum period of 2 years from the date of the procedure, with planned total duration of 4 years of the study, including follow-up time.

• Device Effectiveness- In-stent stenosis

  In this known phenomenon with stents, it is possible that either through local inflammatory reaction or by hyper neointimalization, there can be a buildup of materila on the inner lumen of any stent that is placed.

  Patients will be followed for a minimum period of 2 years from the date of the procedure, with planned total duration of 4 years of the study, including follow-up time.

Study Arms (1)

Device recipient

Device: Codman Enterprise 2 Vascular Reconstruction Device

Interventions

Codman Enterprise 2 Vascular Reconstruction Device 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.

Device recipient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be initially assessed and if included, will undergo procedure that includes use of the device.

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Moody Brain and Spine Institute at Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

Aneurysm

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bartley Mitchell, MD

  Methodist Dallas Medical Center Neurovascular Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: February 24, 2022
• Study Start: February 28, 2017
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-08

Locations

US (1)