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New device aims to seal brain aneurysms safely

NCT ID NCT04289480

Disease control Sponsor: Medos International SARL Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This study looks at a device called ENTERPRISE 2 that helps doctors treat brain aneurysms (a bulging blood vessel in the brain). The device is used during a procedure to block the aneurysm with coils. The study includes 164 people aged 18 to 80 with certain types of brain aneurysms. Researchers will check if the aneurysm stays blocked at 6 months and 1 year after treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 164 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2020

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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; 2. Aged between 18 years and 80 years of age the time of consent; 3. Patient has been diagnosed with ruptured (Hunt-Hess Grade I-III) or unruptured intracranial aneurysm and requires the endovascular treatment; 4. Parent vessel with a diameter of ≥2.5 mm and ≤4 mm; 5. Patient is willing to return to the investigational site for the post-procedure follow-up evaluations. Exclusion Criteria: 1. Severe co-morbidity associated with a life-expectancy of less than twelve months as determined by the investigator; 2. Poor clinical condition with modified Rankin Scale (mRS) score ≥4; 3. Having prior or potential severe allergic reaction to contrast medium; 4. Known allergies to any of the device components, including Enterprise 2 and PROWLER® SELECT™ Plus Infusion Catheter; 5. 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); 6. Arteriovenous malformation (AVM) in the territory of the target aneurysm; 7. Unsuitable for the antithrombotic and/or anticoagulant therapies; 8. Implantation of an intracranial stent associated with aneurysm or symptom distribution within 12 weeks prior to signature of Informed Consent Form; 9. Implantation of a carotid stent associated with aneurysm or symptom distribution within 12 weeks prior to signature of Informed Consent Form; 10. Evidence of active infection; 11. Pregnant or lactating women; 12. 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; 13. Pre-planned staged procedure of target aneurysms.

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Conditions

The condition(s) this trial relates to.

brain aneurysm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intracranial aneurysm

Contacts and locations

Locations

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100029, China

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100070, China

  • Huashan Hospital Shanghai Medical college, Fudan University

    Shanghai, Shanghai Municipality, China

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210008, China

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004, China

  • The first affiliated hospital of Nanchang university

    Nanchang, Jiangxi, 330006, China

  • The first affiliated hospital of Zhengzhou university

    Zhengzhou, Henan, 450052, China

  • Union Hospital, Tongji Medical College, Huazhong University of Science & Technology

    Wuhan, Hubei, 430022, China

  • Zhejiang Hospital

    Hangzhou, Zhejiang, 310007, China

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.