Evolve China PMCF Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Intracranial Aneurysm
• Intervention / Treatment: Device: Surpass Evolve Flow Diverter System

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100191
    • Peking University Third Hospital
  • Beijing, China, 100053
    • Xuanwu Hospital Capital Medical University
  • Beijing, China, 100070
    • Beijing Tiantan Hospital, Capital Medical University
  • Beijing, China
    • Beijing Chao-yang Hospital, Capital Medical University
  • Changchun, China, 130021
    • Bethune First Hospital Of Jilin University
  • Fuzhou, China
    • The First Affiliated Hospital of Fujian Medical University
  • Guangzhou, China
    • Guangdong Second Provincial General Hospital
  • Kunming, China, 650032
    • First Affiliated Hospital of Kunming Medical University
  • Nanyang, China
    • Nanyang Central Hospital
  • Ningbo, China, 315048
    • Ningbo medical center lihuili hospital
  • Qingdao, China, 266003
    • The Affiliated Hospital of Qingdao University
  • Qingdao, China, 266100
    • The Affiliated Hospital of Qingdao University
  • Qingdao, China, 266500
    • The Affiliated Hospital of Qingdao University
  • Shanghai, China, 200434
    • Shanghai Fourth People's Hospital Affiliated To Tongji University
  • Shenzhen, China, 518111
    • South China Hospital of Shenzhen University
  • Shenzhen, China
    • The Eighth Affiliated Hospital, Sun Yat-sen University (Shenzhen Futian)
  • Shijiazhuang, China, 050051
    • The Third Hospital of Hebei Medical University
  • Tangshan, China, 063000
    • Tangshan Workers' Hospital
  • Tianjin, China
    • Tianjin Huanhu Hospital
  • Weifang, China
    • Weifang People's Hospital
  • Xi'an, China, 710061
    • The First Affiliated Hospital of Xi'an Jiaotong University
  • Xiangyang, China, 441000
    • Xiangyang No.1 People's Hospital
  • Zhuhai, China, 519000
    • Zhuhai People's Hospital
  • Zhuhai, China
    • The Fifth Affiliated Hospital, Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months (-3/ +6 months) post-procedure
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.	12 months (-3/+6 months) post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure- and device-related serious adverse events	Procedure- and device-related serious adverse events through 60 months post-procedure	60 months
Key neurological events	Key neurological events of interest through 60 months post-procedure	60 months
Procedural success	Delivery and deployment of one or more study devices to completely cover the neck of the target aneurysm in an individual subject.	Intraprocedural
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.	Intraprocedural
Re-sheathing success	Successful re-sheathing with single attempt.	Intraprocedural

Collaborators and Investigators

• Sponsor: Stryker Neurovascular
• Collaborators: Stryker (Beijing) Healthcare Products Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): August 1, 2031

Study Registration Dates

• First Submitted: April 11, 2024
• First Submitted That Met QC Criteria: April 11, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: intracranial aneurysms; flow diverter system; Surpass Evolve Flow Diverter System; Surpass Evolve
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Antacids; Calcium Carbonate
• Other Study ID Numbers: CDM10001814

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes