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Active, Not Recruiting

NCT Number: NCT06368622

Evolve China PMCF Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surpass Evolve Flow Diverter System

Device

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

Primary outcomes

  1. Neurological death or disabling stroke

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

    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
  2. 100% occlusion without significant parent artery stenosis

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

    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.

Secondary outcomes

  1. Procedure- and device-related serious adverse events

    Time frame: 60 months

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

  2. Key neurological events

    Time frame: 60 months

    Key neurological events of interest through 60 months post-procedure

  3. Procedural success

    Time frame: Intraprocedural

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

  4. Device success

    Time frame: Intraprocedural

    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.

  5. Re-sheathing success

    Time frame: Intraprocedural

    Successful re-sheathing with single attempt.

Sponsors and collaborators

Lead sponsor

Stryker Neurovascular

Industry

Collaborators

  • Stryker (Beijing) Healthcare Products Co., Ltd

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2031
First posted
Apr 16, 2024
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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