AneurysmNCT05254067
Enterprise 2 Vascular Reconstruction Device
An observational study of Aneurysm, run by Methodist Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysm
- What is being tested?
- Codman Enterprise 2 Vascular Reconstruction Device
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2017to 5 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be initially assessed and if included, will undergo procedure that includes use of the device.
Who may be able to join
- 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).
Who cannot join
- Small-necked aneurysms, inappropriate for stenting.
- Inability to tolerate anti-platelet medication.
Trial locations and contacts
1 site in 1 country.
United States1 site
Moody Brain and Spine Institute at Methodist Dallas Medical Center
Dallas, Texas, 75203
About this study
Official title: Treatment of Intracranial Wide-neck Aneurysms Using Stent-assisted Coil Embolization With the Codman Enterprise 2 Vascular Reconstruction Device.
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.
Read the 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 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 aneurysm. The Codman Enterprise 2 Vascular Reconstruction Device is approved by the FDA as a Humanitarian Use Device (HUD) in cases of wide-necked saccular cerebral aneurysms.
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. Secondly, to determine any safety or delivery problems that may occur, or any adverse patient events that may have previously been undocumented.
- Conditions
- Aneurysm
- Being tested
- Codman Enterprise 2 Vascular Reconstruction Device
- Medical subject headings
- Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Codman Enterprise 2 Vascular Reconstruction DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Device recipient | Not described Receives: Device: Codman Enterprise 2 Vascular Reconstruction Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start28 Feb 2017
- Primary completion5 Jan 2026
- Study completion5 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bartley Mitchell, MD, Principal investigator, Methodist Dallas Medical Center Neurovascular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05254067
- Sponsor's protocol ID
- 001.VAS.2017.D
- Status last verified
- May 2026
- First submitted
- 18 Nov 2020
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Intracranial Wide-neck Aneurysms Using Stent-assisted Coil Embolization With the Codman Enterprise 2 Vascular Reconstruction Device.
- ClinicalTrials.gov ID
- NCT05254067
- Acronym / sponsor ID
- 001.VAS.2017.D
- Conditions
- Aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 28 Feb 2017 (actual)
- Primary completion
- 5 Jan 2026 (actual)
- Study completion
- 5 Jan 2026 (actual)
- First posted
- 24 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 aneurysm. The Codman Enterprise 2 Vascular Reconstruction Device is approved by the FDA as a Humanitarian Use Device (HUD) in cases of wide-necked saccular cerebral aneurysms.
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. Secondly, to determine any safety or delivery problems that may occur, or any adverse patient events that may have previously been undocumented.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device recipient | – | Device: Codman Enterprise 2 Vascular Reconstruction Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be initially assessed and if included, will undergo procedure that includes use of the device.
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (2 listed)
- Small-necked aneurysms, inappropriate for stenting.
- Inability to tolerate anti-platelet medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Codman Enterprise 2 Vascular Reconstruction Devicea 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 | Device recipient |
Primary outcome
Device Effectiveness-Stent Migration
Time frame: 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.
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.
Device Effectiveness- Stent Fore-shortening
Time frame: 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.
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.
Device Effectiveness- In-stent stenosis
Time frame: 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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bartley Mitchell, MD principal investigator
Methodist Dallas Medical Center Neurovascular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysm, run by Methodist Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Effectiveness-Stent Migration (time frame: 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.