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New brain aneurysm device tracked for 5 years in 500 patients

NCT ID NCT06368622

Disease control Sponsor: Stryker Neurovascular 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study follows 500 people who received the Surpass Evolve flow diverter, a device placed in brain arteries to treat aneurysms. Researchers will track safety and effectiveness for up to 5 years, focusing on stroke risk and aneurysm closure. The goal is to confirm the device works well in real-world use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Surpass Evolve Flow Diverter System (a mesh tube placed inside the artery to block blood flow to the aneurysm)
What this could lead to
If successful, this study could confirm that the Surpass Evolve device safely and effectively treats brain aneurysms over the long term, supporting its continued use.
What could go wrong
This is an observational study, not a randomized trial, so results may be less definitive. Risks include stroke, device-related complications, and the possibility that long-term outcomes may not meet expectations.

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 500 people

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

Started

Apr 2024

Expected to finish

Aug 2031

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

The study population will be enrolled from up to 40 study sites in China.

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: * Subject age is ≥ 18 and ≤80 years * Subject is eligible for Surpass Evolve FDS IFU, and/or physician intends to treat the subject with Surpass Evolve FDS per his/her judgement * Subject, or subject's legally authorised representative (LAR) has provided signed informed consent using the Ethics Committee (EC)-approved consent form * Subject is willing to comply with scheduled visits and examinations per institutional SOC Exclusion Criteria: * Subject has any non-target intracranial aneurysm treated within 30 days prior to study enrollment * Subject has a planned treatment of a non-target aneurysm in the same vascular territory during participation in the study within 12 months post procedure * Subject has undergone previous treatment where it would interfere with the delivery and/ or placement and/or proper apposition of Surpass Evolve FDS * Subject has acute target aneurysm rupture and/or subarachnoid hemorrhage occurred within 30 days prior to enrollment * Subject has any condition demonstrated as Warning or Precautions in IFU * Antiplatelet and/or anticoagulation therapy (e.g. aspirin and clopidogrel) is contraindicated for the subject * Subject has not received dual anti-platelet agents prior to the procedure * Subject with an active bacterial infection * Subject in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as: * Severe intracranial vessel tortuosity or stenosis; and/or * Intracranial vasospasm not responsive to medical therapy * Female subjects who are pregnant/ nursing, or who are unwilling or unable to take adequate method of contraception prior to the 12-month study follow-up.\* \*If the subject becomes pregnant during her participation, the physician will have to evaluate the risk associated to her continuing participation to the rest of the study. * Enrollment in another trial involving an investigational product and/or drug interfere with study procedure/ results * The investigator determined that the health of the patient may be compromised by the patient's enrollment

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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 Chao-Yang Hospital, Capital Medical University

    Beijing, China

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, 100070, China

  • Bethune First Hospital of Jilin University

    Changchun, 130021, China

  • First Affiliated Hospital of Kunming Medical University

    Kunming, 650032, China

  • Guangdong Second Provincial General Hospital

    Guangzhou, China

  • Nanyang Central Hospital

    Nanyang, China

  • Ningbo Medical Center Lihuili Hospital

    Ningbo, 315048, China

  • Peking University Third Hospital

    Beijing, 100191, China

  • Shanghai Fourth People's Hospital Affiliated To Tongji University

    Shanghai, 200434, China

  • South China Hospital of Shenzhen University

    Shenzhen, 518111, China

  • Tangshan Workers' Hospital

    Tangshan, 063000, China

  • The Affiliated Hospital of Qingdao University

    Qingdao, 266003, China

  • The Affiliated Hospital of Qingdao University

    Qingdao, 266100, China

  • The Affiliated Hospital of Qingdao University

    Qingdao, 266500, China

  • The Eighth Affiliated Hospital, Sun Yat-sen University (Shenzhen Futian)

    Shenzhen, China

  • The Fifth Affiliated Hospital, Sun Yat-sen University

    Zhuhai, China

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, 710061, China

  • The Third Hospital of Hebei Medical University

    Shijiazhuang, 050051, China

  • Tianjin Huanhu Hospital

    Tianjin, China

  • Weifang People's Hospital

    Weifang, China

  • Xiangyang No.1 People's Hospital

    Xiangyang, 441000, China

  • Xuanwu Hospital Capital Medical University

    Beijing, 100053, China

  • Zhuhai People's Hospital

    Zhuhai, 519000, China

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