Intracranial AneurysmEMPOWERNCT04289480

Safety and Effectiveness of ENTERPRISE 2 Device in the Endovascular Treatment of Intracranial Aneurysms

An observational study of Intracranial Aneurysm, run by Medos International SARL at 10 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The study is designed to evaluate the safety and effectiveness of ENTERPRISE 2 vascular reconstruction device and delivery system (hereinafter referred to as ENTERPRISE 2) to facilitate endovascular coil embolization of intracranial aneurysms. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Intracranial Aneurysm
What is being tested?: ENTERPRISE 2 device
Type of treatment: Medical device
How many people: 164 participants
Where: 10 sitesChina
Study dates: 30 Jul 2020to 26 Jul 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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: This study will be conducted in patients with unruptured or ruptured intracranial aneurysm with a parent vessel diameter of ≥2.5 mm and ≤4 mm.

Who may be able to join

Patient (or his/her legal representative) understands the nature of the procedure and provides voluntary written informed consent for the use of his/her peri-procedural and follow-up data;
Aged between 18 years and 80 years of age the time of consent;
Patient has been diagnosed with ruptured (Hunt-Hess Grade I-III) or unruptured intracranial aneurysm and requires the endovascular treatment;
Parent vessel with a diameter of ≥2.5 mm and ≤4 mm;
Patient is willing to return to the investigational site for the post-procedure follow-up evaluations.

Who cannot join

Severe co-morbidity associated with a life-expectancy of less than twelve months as determined by the investigator;
Poor clinical condition with modified Rankin Scale (mRS) score ≥4;
Having prior or potential severe allergic reaction to contrast medium;
Known allergies to any of the device components, including Enterprise 2 and PROWLER® SELECT™ Plus Infusion Catheter;
Angiogram demonstrating that the aneurysm is not appropriate for endovascular treatment (i.e. severe intracranial vessel tortuosity, stenosis, intracranial vasospasm not responsive to medical therapy);
Arteriovenous malformation (AVM) in the territory of the target aneurysm;

Show all 13Show fewer

Unsuitable for the antithrombotic and/or anticoagulant therapies;
Implantation of an intracranial stent associated with aneurysm or symptom distribution within 12 weeks prior to signature of Informed Consent Form;
Implantation of a carotid stent associated with aneurysm or symptom distribution within 12 weeks prior to signature of Informed Consent Form;
Evidence of active infection;
Pregnant or lactating women;
Having participated in clinical studies of other investigational drugs or devices within 30 days prior to signature of Informed Consent Form, excluding epidemiological studies of observational nature or natural history or not involving intervention;
Pre-planned staged procedure of target aneurysms.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

China10 sites

Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong
Zhejiang Hospital
Hangzhou, Zhejiang, 310007
The first affiliated hospital of Nanchang university
Nanchang, Jiangxi, 330006
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
Huashan Hospital Shanghai Medical college, Fudan University
Shanghai, Shanghai Municipality
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004
Union Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, 430022
The first affiliated hospital of Zhengzhou university
Zhengzhou, Henan, 450052

Other trials in China

About this study

Official title: ENTERPRISE 2 Vascular Reconstruction Device and Delivery System Registry: A Multicenter, Prospective, Single-arm Observational Study to Evaluate the Safety and Effectiveness With the Device to Facilitate Endovascular Coil Embolization of Intracranial Aneurysms

Read the detailed description

This is a prospective, multicenter, single-arm observational study, in which enrolled patients will be implanted with the ENTERPRISE 2 for evaluation of safety and effectiveness of ENTERPRISE 2 in real-world applications.

The study population will consist of 164 patients with ruptured or unruptured intracranial aneurysms and a parent vessel diameter of ≥2.5 mm and ≤4 mm. All patients will be implanted with the study device.

The enrolled patients will be followed at 30 days, 180 days, 1 year, 2 years, 3 years, 4 years and 5 years post procedure.

The primary endpoint is the incidence of aneurysm recanalization (at 180 days) evaluated through digital subtraction angiography (DSA). Secondary effectiveness endpoints include incidence of aneurysm recanalization (at 1 year), successful stent/coil placement rate (immediately post procedure), aneurysm occlusion (immediately post procedure, at 180 days and 1 year), incidence of retreatment (at 30 and 180 days, and 1, 2, 3, 4 and 5 years). Safety evaluation include: incidence of disabling stroke or neurological death (at 180 days and 1 year), incidence of in-stent thrombosis (at 180 days and 1 year), and incidence of in-stent stenosis (at 180 days and 1 year). Exploratory endpoints include stent wall apposition performance (intra-procedure), first-time deployment success rate (intra-procedure) and duration of stent deployment (intra-procedure).

Conditions: Intracranial Aneurysm
Being tested: ENTERPRISE 2 device
Keywords: intracranial aneurysms, Neurovascular
Medical subject headings: Intracranial Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ENTERPRISE 2 deviceDevice
The ENTERPRISE 2 Vascular Reconstruction Device is intended for use with occlusive devices in the treatment of intracranial aneurysms.

Study groups in NCT04289480
Study group	Role	What they receive
ENTERPRISE 2 group		The study population enrolled for this clinical study is "aneurysm patients who need stent-assisted coiling treatment", using ENTERPRISE 2 device. Receives: Device: ENTERPRISE 2 device

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of aneurysm recanalization
Incidence of aneurysm recanalization (at 180 days) = number of target aneurysm recanalization (at 180 days) ÷ total number of target aneurysms receiving follow-up × 100%. The results of aneurysm angiography at 180-day follow-up will be obtained through DSA, and the post-procedure immediate aneurysm recanalization shown in angiograms will be graded as per the Raymond-Roy Classification Scale.
The Raymond-Roy Classification at each follow-up time point increased by ≥ one class relative to that immediately after the procedure is defined as recanalization (e.g., Class I immediately after the procedure, Class II at 180-day follow-up).
Measured: at 180 days post procedure

Secondary outcomes (4)

Incidence of aneurysm recanalization
Incidence of aneurysm recanalization (at 1 year) = number of target aneurysm recanalization (at 1 year) ÷ total number of target aneurysms receiving follow-up × 100%. The results of aneurysm angiography at 1 year follow-ups will be obtained through DSA or MRA or CTA.
Measured: at 1 year post procedure
Successful stent/coil placement rate
Successful stent/coil placement rate = number of target aneurysms with successful stent/coil placement ÷ total number of target aneurysms× 100%.
Successful stent/coil placement is defined as successful stent deployment and successful delivery and placement of the coil at the target aneurysm assessed immediately post procedure through angiography.
Measured: immediately post procedure
Aneurysm occlusion
Aneurysm occlusion rate = number of target aneurysms with Raymond-Roy Class I or II aneurysm occlusion÷ total number of target aneurysms× 100%.
The aneurysm occlusion will be assessed by classifying the post-procedure immediate aneurysm occlusion shown in angiograms based on the Raymond-Roy Classification.
Measured: immediately post procedure, at 180 days and at 1 year post procedure
Incidence of retreatment
Incidence of retreatment = number of target aneurysms receiving retreatment during the follow-up ÷ total number of target aneurysms receiving follow-up ×100%.
Retreatment refers to any intervention to the target aneurysm after completing first stent-assisted coil embolization for the target aneurysm.
Measured: at 30 days, 180 days, 1 year, 2 years, 3 years, 4 years and 5 years post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jul 202026 Jul 2026

First posted28 Feb 2020
Study start30 Jul 2020
Primary completion22 Apr 2022
Study completion26 Jul 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Intracranial 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: 164 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04289480
Sponsor's protocol ID: CNV_2018_02
Acronym: EMPOWER
Status last verified: Nov 2026
First submitted: 27 Feb 2020
Last updated: 4 Nov 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage
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Induced Suppression of Platelet Activity in Aneurysmal Subarachnoid Hemorrhage Management-2 (iSPASM-2)
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A Study of Choydar Flow-Directed Mesh Stent in the Treatment of Unruptured Intracranial Aneurysms
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Effect of Bilateral Greater Occipital Nerve Block on Headache After Intracranial Aneurysm Coiling
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All Intracranial Aneurysm trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ENTERPRISE 2 Vascular Reconstruction Device and Delivery System Registry: A Multicenter, Prospective, Single-arm Observational Study to Evaluate the Safety and Effectiveness With the Device to Facilitate Endovascular Coil Embolization of Intracranial Aneurysms
ClinicalTrials.gov ID: NCT04289480
Acronym / sponsor ID: EMPOWER / CNV_2018_02
Conditions: Intracranial Aneurysm
Keywords: intracranial aneurysms, Neurovascular
Study type: Observational
Recruitment status: Completed
Enrolment: 164 participants (actual)
Lead sponsor: Medos International SARLIndustry (pharma, biotech, devices)
Collaborators: Johnson & Johnson Medical (Shanghai) Ltd.
Study start: 30 Jul 2020 (actual)
Primary completion: 22 Apr 2022 (actual)
Study completion: 26 Jul 2026 (actual)
First posted: 28 Feb 2020 (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.

Detailed description

The enrolled patients will be followed at 30 days, 180 days, 1 year, 2 years, 3 years, 4 years and 5 years post procedure.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
ENTERPRISE 2 group	–	Device: ENTERPRISE 2 deviceThe study population enrolled for this clinical study is "aneurysm patients who need stent-assisted coiling treatment", using ENTERPRISE 2 device.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: This study will be conducted in patients with unruptured or ruptured intracranial aneurysm with a parent vessel diameter of ≥2.5 mm and ≤4 mm.

Key inclusion criteria (5 listed)

Patient (or his/her legal representative) understands the nature of the procedure and provides voluntary written informed consent for the use of his/her peri-procedural and follow-up data;
Aged between 18 years and 80 years of age the time of consent;
Patient has been diagnosed with ruptured (Hunt-Hess Grade I-III) or unruptured intracranial aneurysm and requires the endovascular treatment;
Parent vessel with a diameter of ≥2.5 mm and ≤4 mm;
Patient is willing to return to the investigational site for the post-procedure follow-up evaluations.

Key exclusion criteria (13 listed)

Severe co-morbidity associated with a life-expectancy of less than twelve months as determined by the investigator;
Poor clinical condition with modified Rankin Scale (mRS) score ≥4;
Having prior or potential severe allergic reaction to contrast medium;
Known allergies to any of the device components, including Enterprise 2 and PROWLER® SELECT™ Plus Infusion Catheter;
Angiogram demonstrating that the aneurysm is not appropriate for endovascular treatment (i.e. severe intracranial vessel tortuosity, stenosis, intracranial vasospasm not responsive to medical therapy);

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
ENTERPRISE 2 deviceThe ENTERPRISE 2 Vascular Reconstruction Device is intended for use with occlusive devices in the treatment of intracranial aneurysms.	Device	ENTERPRISE 2 group

Primary outcome

Incidence of aneurysm recanalization
Time frame: at 180 days post procedure
Incidence of aneurysm recanalization (at 180 days) = number of target aneurysm recanalization (at 180 days) ÷ total number of target aneurysms receiving follow-up × 100%. The results of aneurysm angiography at 180-day follow-up will be obtained through DSA, and the post-procedure immediate aneurysm recanalization shown in angiograms will be graded as per the Raymond-Roy Classification Scale. The Raymond-Roy Classification at each follow-up time point increased by ≥ one class relative to that immediately after the procedure is defined as recanalization (e.g., Class I immediately after the procedure, Class II at 180-day follow-up).

4 secondary outcomes

Incidence of aneurysm recanalization
Time frame: at 1 year post procedure
Successful stent/coil placement rate
Time frame: immediately post procedure
Aneurysm occlusion
Time frame: immediately post procedure, at 180 days and at 1 year post procedure
Incidence of retreatment
Time frame: at 30 days, 180 days, 1 year, 2 years, 3 years, 4 years and 5 years post procedure

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 4 Nov 2026.
Individual participant dataSharing planned: Yes. Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.

Related trials for Intracranial Aneurysm

Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
RecruitingObservational study
Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Spontaneous, Subarachnoid Hemorrhage, Aneurysmal
Not yet recruitingPhase 1/2
Induced Suppression of Platelet Activity in Aneurysmal Subarachnoid Hemorrhage Management-2 (iSPASM-2)
Aneurysmal Subarachnoid Hemorrhage
RecruitingObservational study
A Study of Choydar Flow-Directed Mesh Stent in the Treatment of Unruptured Intracranial Aneurysms
Intracranial Aneurysm
Not yet recruiting
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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.

Xinjian Yang, Professor principal investigator

Beijing Tiantan Hospital

Shiqing Mu, Professor principal investigator

Beijing Tiantan Hospital

Qingrong Zhang, Professor principal investigator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Intracranial Aneurysm, run by Medos International SARL at 10 sites in China.

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 5 inclusion and 13 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 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in China. 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?

Incidence of aneurysm recanalization (time frame: at 180 days post procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04289480.

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 4 Nov 2026.