Evolve China PMCF Study

Stryker

Status: Enrolling

Conditions: Intracranial Aneurysm

Treatments: Device: Surpass Evolve Flow Diverter System

Study type: Observational

Funder types: Industry

Identifiers

NCT06368622

CDM10001814

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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