Evolve China PMCF Study

Launched by STRYKER NEUROVASCULAR · Apr 11, 2024

Keywords

ClinConnect Summary

The Evolve China PMCF Study is a clinical trial focused on evaluating a medical device called the Surpass Evolve Flow Diverter System, which is used to treat intracranial aneurysms—bulges in blood vessels in the brain that can be dangerous if they rupture. This study is observational, meaning researchers will follow patients who are already being treated with this device to see how well it works over time. The study will take place over eight years, with up to five years of follow-up care for each participant.

To be eligible for this study, participants must be between 18 and 80 years old and should be considered suitable for treatment with the Surpass Evolve device by their doctor. They need to provide consent to participate and agree to follow-up visits as recommended. However, certain conditions may exclude someone from participating, such as recent treatments for other aneurysms, certain medical conditions, or if they are pregnant. Participants will be monitored regularly as part of their usual care to ensure their safety and to gather important information about the device's performance.

Gender

ALL

Eligibility criteria

• 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