A Post-Market Clinical Follow-up Study to Evaluate the Long-Term Safety and Effectiveness of Surpass Evolve Flow Diverter System
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Intracranial Aneurysm
- Sponsor
- Stryker Neurovascular
- Enrollment
- 500
- Locations
- 42
- Primary Endpoint
- Neurological death or disabling stroke
- Status
- Active, not recruiting
- Last Updated
- last month
Overview
Brief 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.
Investigators
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
Outcomes
Primary Outcomes
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
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
- Procedure- and device-related serious adverse events(60 months)
- Procedural success(Intraprocedural)
- Key neurological events(60 months)
- Device success(Intraprocedural)
- Re-sheathing success(Intraprocedural)