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Intracranial AneurysmNCT06368622

Evolve China PMCF Study

An observational study of Intracranial Aneurysm, run by Stryker Neurovascular at 24 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

A prospective, multi-center, single-arm, open-label, observational, post-market clinical follow-up. The expected duration of the study is 8 years (including up to 5-years' follow-up). Each subject will be followed up per standard of care (SoC) at each study site. 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?
Surpass Evolve Flow Diverter System
Type of treatment
Medical device
How many people
500 participants
Where
24 sitesChina
Study dates
24 Apr 2024to Aug 2031
Phase
Observational
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

China24 sites

  • Xuanwu Hospital Capital Medical University

    Beijing, 100053

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, 100070

  • Peking University Third Hospital

    Beijing, 100191

  • Beijing Chao-Yang Hospital, Capital Medical University

    Beijing

  • Bethune First Hospital of Jilin University

    Changchun, 130021

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou

  • Guangdong Second Provincial General Hospital

    Guangzhou

  • First Affiliated Hospital of Kunming Medical University

    Kunming, 650032

  • Nanyang Central Hospital

    Nanyang

  • Ningbo Medical Center Lihuili Hospital

    Ningbo, 315048

  • The Affiliated Hospital of Qingdao University

    Qingdao, 266003

  • The Affiliated Hospital of Qingdao University

    Qingdao, 266100

  • The Affiliated Hospital of Qingdao University

    Qingdao, 266500

  • Shanghai Fourth People's Hospital Affiliated To Tongji University

    Shanghai, 200434

  • South China Hospital of Shenzhen University

    Shenzhen, 518111

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

    Shenzhen

  • The Third Hospital of Hebei Medical University

    Shijiazhuang, 050051

  • Tangshan Workers' Hospital

    Tangshan, 063000

  • Tianjin Huanhu Hospital

    Tianjin

  • Weifang People's Hospital

    Weifang

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, 710061

  • Xiangyang No.1 People's Hospital

    Xiangyang, 441000

  • Zhuhai People's Hospital

    Zhuhai, 519000

  • The Fifth Affiliated Hospital, Sun Yat-sen University

    Zhuhai

Other trials in China

About this study

Official title: A Post-Market Clinical Follow-up Study to Evaluate the Long-Term Safety and Effectiveness of Surpass Evolve Flow Diverter System

A prospective, multi-center, single-arm, open-label, observational, post-market clinical follow-up. The expected duration of the study is 8 years (including up to 5-years' follow-up). Each subject will be followed up per standard of care (SoC) at each study site.

Being tested
Surpass Evolve Flow Diverter System
Keywords
intracranial aneurysms, flow diverter system, Surpass Evolve Flow Diverter System, Surpass Evolve
Medical subject headings
Intracranial Aneurysm

What participants receive

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

  • Surpass Evolve Flow Diverter SystemDevice

    Endovascular treatment with Surpass Evolve Flow Diverter System was performed in patients diagnosed with intracranial aneurysms

What is being measured

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

  1. Neurological death or disabling stroke

    Neurological death or disabling stroke at 12 months post-procedure (-3/ + 6 months).

    • Neurological death defined as stroke-related death
    • Disabling stroke defined as stroke in the treated vascular territory that results in a mRS score ≥ 3, assessed by a qualified investigator at a minimum 90-days post stroke event

    Measured: 12 months (-3/ +6 months) post-procedure

  2. 100% occlusion without significant parent artery stenosis

    A composite of 100% occlusion (defined as Raymond-Roy class 1) of the target aneurysm without significant parent artery stenosis (significant stenosis defined as ˃50% stenosis), per the assessment of images required, and with no retreatment of target aneurysm at 12 months (-3/+6 months) post-procedure.

    Measured: 12 months (-3/+6 months) post-procedure

Secondary outcomes (5)

  1. Procedure- and device-related serious adverse events

    Procedure- and device-related serious adverse events through 60 months post-procedure

    Measured: 60 months

  2. Key neurological events

    Key neurological events of interest through 60 months post-procedure

    Measured: 60 months

  3. Procedural success

    Delivery and deployment of one or more study devices to completely cover the neck of the target aneurysm in an individual subject.

    Measured: Intraprocedural

  4. Device success

    Delivery and deployment of a study device to completely cover the neck of the target aneurysm, either alone or in conjunction with another Surpass Evolve FDS.

    Measured: Intraprocedural

  5. Re-sheathing success

    Successful re-sheathing with single attempt.

    Measured: Intraprocedural

Timeline

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

  1. First posted16 Apr 2024
  2. Study start24 Apr 2024
  3. Primary completionNov 2027 (estimated)
  4. Study completionAug 2031 (estimated)

Resources

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
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06368622
Sponsor's protocol ID
CDM10001814
Status last verified
Mar 2026
First submitted
11 Apr 2024
Last updated
30 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Intracranial Aneurysm, run by Stryker Neurovascular at 24 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 4 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 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?

This study is still under way. Results are not available in the source record yet.

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?

Neurological death or disabling stroke (time frame: 12 months (-3/ +6 months) post-procedure). The study lists 2 primary outcomes in all. 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 NCT06368622.

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 30 Mar 2026.

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